Aspirators, components thereof, and assembly and fit thereof

ABSTRACT

In part, the disclosure relates to an aspirator having a handle that includes a suction connector extending from a proximal end face, a substantially cylindrical sleeve mount having an outer surface and a shoulder. A tubular member defining a bore and having flared end disposed in a suction head having one or more cantilevered protuberances can extend from the sleeve mount. The substantially cylindrical sleeve mount is in relief with respect to the shoulder and extends distally therefrom. The substantially cylindrical sleeve mount defines an aperture. The suction connector bore, bore of tubular member, inner cavity of handle and suction head bore define a fluid flow path or cavity. The aspirator can include a sleeve that receives the suction head. The sleeve engages and interferes with the sleeve mount. The suction head and sleeve&#39;s inner wall have one or more engineered clearances between them to enhance assembly.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. 119(e)from U.S. Provisional Application No. 62/364,653 filed on Jul. 20, 2016,the disclosure of which is herein incorporated by reference in itsentirety.

BACKGROUND

A number of different devices may be used to remove fluids from acavity, or other region of a patient, during a medical procedure. Oftenthese devices will implement removal via suction. In general, devicesused for producing suction, moving material by suction, or collectingmaterial by suction, such as various types of aspirators, have remainedlargely the same since their initial development. Typically, a hollowtubular instrument is connected to a partial vacuum. The partial vacuumcreates suction through the tubular instrument, thus removing fluid,tissue, or other material from a cavity or region of the body.

An aspirator typically includes a tip that is inserted into a surgicalsite, wound, or other bodily hole. The tip is generally elongated inshape and may include a handheld or grip section to facilitate using theaspirator. The proximal end of the tip is connected to a tube connectedto a suction pump, providing the partial vacuum and thus suction to thetip. During use, the distal end of the aspirator tip is inserted intothe patient. This distal end may have one or more openings into whichgases, fluids, and materials may flow.

During operation, pieces of tissue and other debris may be suspended inthe bodily fluid, thus clogging the aspirator. In addition, as istypically the case, surgical irrigation is used to wash a wound,tissues, organs and surgical cavities as part of various medicalprocedures. As a result, irrigation solution is introduced into thebody, which is typically removed at a later stage. Various materials canalso become entrained in the irrigation solution. There are various waysin which fluid flow can be interrupted or aspirator ports can be cloggedduring aspirator operation.

For example, openings at an end of the aspirator, the location wherefluid first enters the device, are particularly vulnerable to clogging.One solution to this problem involves covering the distal end of theaspirator with a sleeve formed with a plurality of small holes. Theplurality of small holes may prevent the tissue from reaching theopening of the aspirator. However, the plurality of small holes maystill allow the fluid sleeve to become clogged. As the fluid sleevebecomes clogged, suction is no longer distributed uniformly among theremaining unclogged holes. This condition may create additionalundesirable suction in a particular area, thus pulling surroundingtissue into the holes of the sleeve and simultaneously blocking orotherwise reducing the suctioning of unwanted material during theprocedure.

One solution to this problem of clogging involves including additionalholes in the end of the aspirator, near the connection between thesleeve and the aspirator. Because these additional holes are spaced fromthe wound, bodily hole, or surgical site, the additional holes are lesslikely to become clogged with tissue or debris. However, these holes areoften vulnerable to obstruction by the hands or fingers of the user(e.g., by the hand holding the aspirator). Likewise, these holes may beobstructed or blocked when resting the aspirator and sleeve combinationagainst another object, such as the patient's body, a table, ordressings surrounding the surgical site. Further, given the introductionof an irrigation solution and the entrainment of material therein, thepotential exists for unintentionally suction applied to tissue andtearing at tissue surface or otherwise damaging it through the processof removing unwanted material from a surgical site using a suctiondevice.

Therefore, a need exists for improved surgical aspirator and sleevecombinations that address these challenges and others relating to auser's tactile user experience when using such combinations and asotherwise described in more detail herein.

SUMMARY

In part, the disclosure relates to an aspirator having a handle thatincludes a suction connector extending from a proximal end face, asubstantially cylindrical sleeve mount having an outer surface and ashoulder. A tubular member defining a bore and having flared enddisposed in a suction head having one or more cantilevered protuberancescan extend from the sleeve mount. The substantially cylindrical sleevemount is in relief with respect to the shoulder and extends distallytherefrom. The substantially cylindrical sleeve mount defines anaperture. The suction connector bore, bore of tubular member, innercavity of handle and suction head bore define a fluid flow path orcavity. The aspirator can include a sleeve that receives the suctionhead. The sleeve engages and interferes with the sleeve mount. Thesuction head and sleeve's inner wall have one or more engineeredclearances between them to enhance assembly. In one embodiment, thedisclosure relates to a sleeve and aspirator combination or assembly. Inone embodiment, the disclosure relates to a sleeveless actuator orsuction device.

In part, the disclosure relates to various aspirator interference fitand assembly features and related embodiments.

In part the disclosure relates to an aspirator. The aspirator includesan elongate handle defining an fluid flow cavity, the elongate handleincludes a proximal end face, a suction connector extending from theproximal end face, a substantially cylindrical sleeve mount includes anouter surface, and a shoulder, wherein the substantially cylindricalsleeve mount is in relief with respect to the shoulder and extendsdistally therefrom, wherein the substantially cylindrical sleeve mountdefines an aperture, wherein the suction connector defines a suctionconnector bore, the suction connector bore in fluid communication withthe aperture and the fluid flow cavity.

The aspirator may also include a tubular member extending from theaperture, wherein the tubular member includes a proximal tube end and adistal tube end, wherein the proximal tube end is disposed in andsecured by the handle, the tubular member defining a tubular memberbore, the tubular member bore in fluid communication with the flowcavity and suction connector bore. The aspirator may also include anelastic sleeve, the elastic sleeve defining a plurality of vent holes, asleeve lumen and a sleeve inner wall, the elastic sleeve includes asleeve tip and a sleeve rim, wherein the sleeve rim defines a sleeveopening.

In one embodiment, the substantially cylindrical sleeve mount includes amount thickness and a mount length, wherein the mount thickness andmount length are sized such that during sleeve installation on thesleeve mount the sleeve inner wall interferes with the outer surface ofthe sleeve mount upon the substantially cylindrical sleeve mountentering the sleeve lumen. In one embodiment, interference betweensleeve inner wall and the outer surface continues along the mount lengthduring the installation, wherein the installation is complete when thesleeve rim contacts the shoulder. In one embodiment, the aspirator mayalso include an elastic sleeve, the elastic sleeve defining a pluralityof vent holes, a sleeve lumen and a sleeve inner wall, the elasticsleeve includes a sleeve tip and a sleeve rim, wherein the sleeve rimdefines a sleeve opening, wherein the sleeve lumen is sized to receivethe tubular member and to interfere with the outer surface of the sleevemount upon the sleeve mount entering the sleeve lumen.

In one embodiment, the interference between sleeve inner wall and theouter surface continues along an engagement length during installation,wherein the installation is complete when the sleeve rim contacts at theshoulder. In one embodiment, the substantially cylindrical sleeve mounthas a longitudinal axis, wherein an angle of taper of the outer surfaceof the substantially cylindrical sleeve mount measured relative to thelongitudinal axis is less than about 2 degrees. In one embodiment, asleeve engagement zone is defined by a region of overlap between outersurface and sleeve inner wall wherein interference between the elasticsleeve and substantially cylindrical sleeve mount occurs in the sleeveengagement zone. In one embodiment, the distal tube end is flared.

The aspirator may also include a suction head includes a body, a distalsuction head end face and a proximal suction head end face, the suctionhead attached to the distal tube end; the body defining a primaryopening and a suction head bore, the distal suction head end facesurrounding the primary opening, the proximal suction head end facedefining an output aperture, the output aperture in fluid communicationwith the suction head bore and the primary opening; and a plurality ofprotuberances disposed radially around the primary opening, eachprotuberance includes a first region and a second region, the firstregion cantilevered relative to the distal end face and extendingdistally relative to the primary opening, the second region extendingfrom body to define a ridge.

The aspirator may also include a suction head defining an opening and asuction head bore, the opening in fluid communication with the suctionhead bore, the suction head attached to the distal tube end, the suctionhead includes a plurality of protuberances symmetrically arranged aroundthe opening, each of the protuberances being an extension of a surfaceof the body in or more directions. In one embodiment, the fluid flowcavity transports one or more fluids including, without limitation,liquids, gases, and the foregoing with one or more solid materialsdisposed therein.

In one embodiment, the flow cavity of the handle is also defined by aproximal cavity, a distal cavity, and a middle cavity disposed betweenthe distal cavity and the proximal cavity. In one embodiment, a diameterof the middle cavity is less than diameter of proximal cavity atinterface of middle cavity and proximal cavity. The aspirator may alsoinclude a suction head attached to the distal tube end, wherein anengineered clearance distance is defined between a surface of thesuction head and an inner surface of the sleeve such that a skewingangle is constrained when elastic sleeve is installed on handle, whereinthe tubular member includes a bend.

In one embodiment, the fluid flow cavity is further defined by thesuction connector bore; an elongate section of the tubular member boredisposed in the handle and in fluid communication with the suctionconnector bore; and a transitional cavity disposed between the suctionconnector bore and the elongate section of the tubular member bore. Thetransitional cavity is disposed within the handle in one embodiment. Inone embodiment, a diameter of the transitional cavity is less than adiameter of the suction connector bore at interface of transitionalcavity and suction connector bore.

In one embodiment, the skewing angle is defined by longitudinal axis ofthe tubular member proximal to the bend and longitudinal axis of sleevedistal to the bend. The aspirator may also include a tubular memberdefining a bend, the tubular member includes a proximal tube end and adistal tube end, the proximal tube end disposed in the handle, thetubular member extending from substantially cylindrical sleeve mount,wherein a section of the tubular member distal to the bend defines atubular longitudinal axis, wherein the substantially cylindrical sleevemount is sized to receive an elastic sleeve such that the bend isdisposed within the sleeve.

In one embodiment, a section of the elastic sleeve distal to the benddefines a sleeve longitudinal axis, wherein a clearance is definedbetween a sleeve inner surface of the elastic sleeve and an outersurface of the tubular member by a skewing angle between thelongitudinal axis and the sleeve longitudinal axis.

In one embodiment, the interference is a nominal interference of thesleeve inner wall to a mating diameter of the outer surface of thesleeve mount, wherein the nominal interference ranges from about 0.010inches to about 0.020 inches. In one embodiment, the engagement lengthranges from about 0.400 to about 0.800 inches.

In part, the disclosure relates to a method of providing tactilefeedback for an aspirator. The method includes providing an aspiratorsleeve includes a sleeve wall, the sleeve wall defining a sleeve cavityand a proximal sleeve end face; providing an aspirator handle includes asubstantially cylindrical sleeve mount and a tubular member, the tubularmember extending from the substantially cylindrical sleeve mount;initiating interference between sleeve wall and substantiallycylindrical sleeve mount when sleeve mount enters the sleeve cavity; andmaintaining interference between sleeve wall and substantiallycylindrical sleeve mount from initiation of interference until theaspirator sleeve is installed.

In one embodiment of the method, maintaining interference may alsoinclude varying level of interference while maintaining interferenceover a first portion of an engagement distance along the sleeve mount.In one embodiment of the method, varying level of interference may alsoinclude increasing the level of interference in response to a firstrange of assembly forces over the first portion of engagement distancealong the sleeve mount. In one embodiment of the method, varying levelof interference may also include increasing level of interference inresponse to a second range of assembly forces over a second portion ofengagement distance along the sleeve mount.

In one embodiment of the method, a first rate of increasing assemblyforce for the first portion of the engagement distance is greater than asecond rate of increasing assembly force for the second portion of theengagement distance. In one embodiment of the method, the first portionof the engagement distance includes a region of the outer surface thatinitially interferes with substantially cylindrical sleeve mount. In oneembodiment of the method, the second portion of the engagement distanceincludes a region of the outer surface that is bounded proximally by ashoulder of the handle. In one embodiment of the method, the method mayalso include moving substantially cylindrical sleeve mount into sleevecavity over an engagement distance until aspirator sleeve is installedon substantially cylindrical sleeve mount, wherein interference occursover the engagement distance.

In one embodiment of the method, the method may also include selectingsleeve and selecting handle such that when sleeve is installed onsubstantially cylindrical sleeve mount, a combination of sleeve andhandle has appearance of a Poole suction device. In one embodiment ofthe method, the method may also include in response to installation ofsleeve on sleeve mount by a user, providing tactile feedback to the userduring installation until the sleeve is fully engaged relative to thesleeve mount.

In one embodiment of the method, the method may also include, inresponse to installation of sleeve on sleeve mount by a user, providingtactile feedback to the user during installation until the sleeve isfully engaged relative the sleeve mount. In one embodiment of themethod, the tactile feedback is an assembly force, wherein the assemblyforce provided to the user is increasing until the sleeve reaches ashoulder disposed around the sleeve mount. In one embodiment of themethod, the interference is a nominal interference of the sleeve wall toa mating diameter of the substantially cylindrical sleeve mount, whereinthe nominal interference ranges from about 0.010 inches to about 0.020inches. In one embodiment of the method, the interference is maintainedover an engagement length that ranges from about 0.400 to about 0.800inches. In one embodiment, the method is a method of assembling asuction device.

In part, the disclosure relates to various suction head features andrelated embodiments.

In part, the disclosure relates to a suction apparatus, the suctionapparatus includes a suction head includes a body, a distal end face anda proximal end face; the body defining a primary opening and a suctionhead bore, the distal end face surrounding the primary opening, theproximal end face defining an output aperture, the output aperture influid communication with the suction head bore and the primary opening;and a plurality of protuberances disposed around the primary opening,each protuberance includes a first region and a second region, the firstregion cantilevered relative to the distal end face and extendingdistally relative to the primary opening, the second region extendingfrom body distally from one of the four lobes. In one embodiment, thesecond region is a ridge, fin, or other shaped structure. In oneembodiment of the suction apparatus, the plurality of protuberances istwo protuberances. In one embodiment of the suction apparatus, theplurality of protuberances is four protuberances.

In one embodiment of the suction apparatus, the suction head includesfour lobes, wherein the plurality of protuberances is two or moreprotuberances, at least one protuberance extends distally from one ofthe four lobes. In one embodiment of the suction apparatus, the suctionapparatus may also include a tubular member, the tubular member includesa flared distal tip, the flared distal tip disposed in the body in fluidcommunication with the primary opening and suction head bore, thetubular member extending from the output aperture. In one embodiment ofthe suction apparatus, the flared distal tip includes a flaring angle,the flaring angle extending from longitudinal axis of tubular member toinner surface of flared distal tip, wherein the flaring angle is greaterthan about 2 degrees and less than about 40 degrees. In one embodimentof the suction apparatus, one or more of the first regions extendingdistally relative to the primary opening define one or more flow pathsin fluid communication with the output aperture.

In one embodiment of the suction apparatus, the one or more flow pathsare also defined relative to a tissue surface, the tissue surfacetented, by one or more of the first regions, to form at least a portionof the one or more flow paths. In one embodiment of the suctionapparatus, the suction apparatus may also include a handle includes asubstantially cylindrical sleeve mount, wherein the tubular memberincludes a proximal tubular member end face, wherein the proximaltubular member end face is disposed with the handle, wherein the tubularmember extends from the substantially cylindrical sleeve mount.

In part, the disclosure relates to a suction apparatus, the suctionapparatus includes a housing includes a distal end face and a proximalend face, the housing includes a first shape, a central bore defined bythe housing and spanning the proximal end face and the distal end face,the central bore defining a longitudinal axis of the suction head, Nvent ports arranged in a first configuration relative to thelongitudinal axis, wherein each of the N vent ports is defined by thehousing, and M protuberances arranged in a second configuration relativeto the longitudinal axis wherein each of the protuberances is defined bythe housing, wherein a first portion of one or more of the Mprotuberances is cantilevered relative to the proximal end face.

In one embodiment of the suction head, one or more of the Mprotuberances extend from the housing such that upon tissue contact theone or more protuberances at least partially define one or more fluidflow paths. In one embodiment of the suction head, the suction head mayalso include a handle member and a tubular member defining a tubularbore, the tubular member includes a flared end and a proximal tubularend face, the flared end disposed in the suction head and in fluidcommunication with the central bore, the handle member attached to theproximal tubular end face.

In one embodiment of the suction head, a flaring angle of the flared endis less than about 40 degrees. In one embodiment of the suction head,the housing, the tubular member, and the handle member are of a unitaryconstruction. In one embodiment of the suction head, one or more of theM protuberances include a second region cantilevered relative to andextending radially from a surface of the housing. In one embodiment ofthe suction head, the housing includes two or more lobes, wherein one ofthe M protuberances extend from at least one of the two or more lobes.In one embodiment of the suction head, the second configuration of Mprotuberances includes a symmetric arrangement of each of theprotuberances relative to the longitudinal axis.

In one embodiment of the suction head, M is even, and wherein a channelis disposed between each pair of protuberances, the channel defined bythe housing, wherein one or more of the N vent ports is disposed in eachchannel. In one embodiment of the suction head, the housing includesfour lobes arranged around the central bore in a cruciform arrangement,wherein M is 2 and the second configuration includes one of theprotuberances extending distally from at least one of the lobes. In oneembodiment of the suction head, the M protuberances protrude from theproximal end face of the housing, and wherein the housing defines aplurality of recessed regions at the proximal end face. In oneembodiment of the suction head, N is a natural number and M is a naturalnumber less than or equal to eight. In one embodiment of the suctionhead, the first shape is selected from the group consisting of a bulb, aknob, ellipsoidal, a conic section, a frustum, a sphere, a truncatedellipsoid, a half sphere, and a shape defined by a surface ofrevolution.

In one embodiment of the suction head, the second end of the housingtapers to a substantially elliptical opening, the substantiallyelliptical opening defined by the housing and in fluid communicationwith the central bore. In one embodiment of the suction head, thesuction head may also include a tubular member, the tubular memberdisposed in the housing and extending through the substantiallyelliptical opening, the tubular member in fluid communication with thecentral bore and the N vent ports. In one embodiment of the suctionhead, the suction head may also include a handle includes asubstantially cylindrical sleeve mount, a tubular member extending fromthe handle and having a flared proximal end face, wherein the housing issecured to the proximal end face.

In part, the disclosure relates to a suction apparatus, the suctionapparatus includes a body defining a bore, the bore defining alongitudinal axis, the body having a proximal end and a distal end, thebore in fluid communication with a central opening, one or moreprotuberances arranged around the longitudinal axis, each of the one ormore protuberances being an extension of a surface of the body in ormore directions, wherein a distal end of each protuberance extendsbeyond the central opening a distance D; and a plurality of trenchesarranged around the longitudinal axis, each of the trenches being adeformation of the surface of the body, wherein the plurality oftrenches define a plurality of vent holes. In one embodiment of thesuction apparatus, D ranges from about 0.002 inches to about 0.1 inches.In one embodiment of the suction apparatus, the suction head has acruciform cross-sectional shape defined by the central opening and foursurface extensions of the housing, wherein the one or more protuberancesis two protuberances or four protuberances.

In one embodiment of the suction apparatus, the body includes aring-shaped distal end face encircling the bore and the distal end ofeach protuberance cantilevered relative to the ring-shaped distal endface. In one embodiment of the suction apparatus, the distal end of eachprotuberance is arranged relative to the central bore such that upontissue contact the distal end protuberances define one or more fluidflow paths relative to the central bore. In one embodiment of thesuction apparatus, the one or more fluid flow paths are also defined byone or more tissue regions.

In part, the disclosure relates to various internal geometric featuresof a suction handle, associated flow paths and related embodiments.

In one aspect, the disclosure relates to an aspirator that includes: ametal tubular member includes a flared end and a proximal tubular end,the tubular member defining a bore, the proximal tubular end includes aninner diameter and an outer diameter; and an elongate handle includes adistal end face defining an aperture, the metal tubular member extendingfrom the aperture, wherein the proximal tubular end, an elongate sectionof the bore and the metal tubular member are disposed in the handle, asuction connector extending from the proximal end face, the suctionconnector and the elongate handle defining a first flow cavity, theelongate handle defining a second flow cavity, the second flow cavitydisposed within the handle, the second flow cavity adjacent to and influid communication with the first flow cavity, the second flow cavityadjacent to the proximal tubular end and in fluid communication with thebore, wherein the first flow cavity, the second flow cavity and theelongate section of the bore define an inner flow path within thehandle.

The aspirator may also include a suction head defining a third flowcavity in fluid communication with the inner flow path, the suction headattached to the flared end. In one embodiment, the suction head and thehandle include a polymer material. In one embodiment of the aspirator,the first flow cavity has a truncated cone shape, wherein a diameter ofthe second flow cavity is less than diameter of the first flow cavity atan interface of the first flow cavity and the second flow cavity. In oneembodiment of the aspirator, the distal end face of handle includes asubstantially cylindrical sleeve mount.

In one embodiment of the aspirator, a diameter of second flow cavity isgreater than the outer diameter. In one embodiment of the aspirator,interface between first flow cavity and second flow cavity includes astepped transition. In one embodiment of the aspirator, the metaltubular member is a cylindrical tube or a tapered tube. In oneembodiment of the aspirator, the flared end has a flared outer diameter,wherein the ratio of the flared outer diameter to the outer diameter ofthe proximal tubular end is less than about 1.4. In one embodiment ofthe aspirator, a length of the second flow cavity is less than a lengthof the first flow cavity. In one embodiment of the aspirator, a lengthof the elongate section of the bore in the handle is greater than thelength of the second flow cavity.

In one embodiment of the aspirator, an inner diameter of the bore isless than or equal to a diameter of the second flow cavity. In oneembodiment of the aspirator, a curved transition is defined at ajunction of an inner surface of the third flow cavity of the suctionhead and the flared end. In one embodiment of the aspirator, the curvedtransition is a radius or smooth curve. In one embodiment of theaspirator, the outer diameter of the tubular member is greater than orequal to a diameter of the second flow cavity. In one embodiment of theaspirator, a diameter of first flow cavity is less than about 0.5inches, wherein the diameter of the first flow cavity is widestdimension of inner flow path of handle.

In one aspect, the disclosure relates to an aspirator that includes: ametal tubular member includes a flared end and a proximal tubular end,the tubular member defining a bore, the proximal tubular end includes aninner diameter and an outer diameter; a suction head attached to theflared end, the suction head defining a suction head bore, the suctionhead bore in fluid communication with the bore; and an elongate handleincludes a suction connector, and a section of the tubular memberdisposed within the handle, the handle defining a proximal flow cavityadjacent to and in fluid communication with the suction connector, thehandle defining a transitional flow cavity between the section of thetubular member and the proximal flow cavity; the section of the tubularmember, the transitional flow cavity and the proximal flow cavitydefining an inner flow cavity in fluid communication with the bore ofthe metal tubular member and the suction head bore, wherein a diameterof transitional flow cavity is less than diameter of proximal flowcavity at interface of transitional flow cavity and proximal flowcavity.

In one embodiment of the aspirator, the flared end has a flared outerdiameter, wherein the ratio of the flared outer diameter to the outerdiameter of the first end is less than about 1.4. In one embodiment ofthe aspirator, the diameter of transitional cavity is greater than theouter diameter. In one embodiment of the aspirator, the interfacebetween transitional flow cavity and proximal flow cavity includes astepped transition. In one embodiment of the aspirator, the tubularmember is a cylindrical tube or a tapered tube.

In one embodiment of the aspirator, the proximal flow cavity is atruncated cone. In one embodiment of the aspirator, a curved transitionis defined at a junction of an inner surface of the suction head boreand the flared end. In one embodiment of the aspirator, the curvedtransition is a radius or smooth curve. In one embodiment of theaspirator, the outer diameter of the tubular member is greater than orequal to a diameter of the transitional flow cavity. In one embodimentof the aspirator, the inner diameter of the tubular member is less thana diameter of the transitional flow cavity

In part, the disclosure relates to various suction head, sleeve andaspirator clearances, skewing angles constrained thereby and relatedembodiments.

In one aspect, the disclosure relates to an aspirator that includes: ahandle includes a shoulder and a sleeve coupler, the sleeve couplerdefining an aperture, the handle and the sleeve coupler includes alongitudinal axis, wherein the sleeve coupler is in relief relative tothe shoulder; a tubular member defining a bend, the tubular memberincludes a proximal tube end and a distal tube end, the proximal tubeend disposed in the handle, the tubular member extending from the sleevecoupler and the aperture; and a suction head includes a distal end face,the suction head attached to the tubular member, wherein a clearance isdefined between a sleeve inner surface of the elastic sleeve and thesuction head.

In one embodiment of the aspirator, the clearance ranges from about0.080 inches to about 0.11 inches, wherein the clearance is between thedistal end face of the suction head and the sleeve inner surface. In oneembodiment of the aspirator, the clearance ranges from about 0.001inches to about 0.020 inches, wherein the clearance is between a side ofthe suction head and the sleeve inner surface. In one embodiment of theaspirator, the clearance ranges from about 0.005 inches to about 0.100inches, wherein the clearance is between the distal end face of thesuction head and the sleeve inner surface. In one embodiment of theaspirator, a section of the tubular member distal to the bend defines atubular longitudinal axis, wherein the sleeve coupler is sized toreceive an elastic sleeve such that the bend is disposed within thesleeve, wherein a section of the elastic sleeve distal to the benddefines a sleeve longitudinal axis.

In one embodiment of the aspirator, the clearance constrains a firstskewing angle range between the longitudinal axis and the sleevelongitudinal axis. In one embodiment of the aspirator, the first skewingangle range is from about 24° to about 32°. In one embodiment of theaspirator, the first skewing angle range is from about 33.5° to about41.5°. In one embodiment of the aspirator, the first skewing angle rangeis from about 32° to about 40°. In one embodiment of the aspirator, theclearance constrains a second skewing angle range between a portion ofthe sleeve and a portion of the tubular member after the bend.

In one embodiment of the aspirator, the second skewing angle range isfrom about 5° to about 15°. In one embodiment of the aspirator, thesecond skewing angle range is from about 2° to about 6°. In oneembodiment of the aspirator, the elastic sleeve defines a plurality ofvent holes, a sleeve lumen and the sleeve inner surface, the elasticsleeve includes a sleeve tip and a sleeve rim, wherein the sleeve rimdefines a sleeve opening. In one embodiment of the aspirator, a distalend face of the sleeve is next to the shoulder, wherein combination ofsleeve and aspirator resembles a Poole suction device. In one embodimentof the aspirator, a surface of the tubular member at the bend contactsthe sleeve inner surface at one or more regions.

In one aspect, the disclosure relates to an aspirator that includes: anelastic sleeve includes a proximal sleeve end, a distal sleeve end andan inner sleeve wall, the proximal sleeve end and inner sleeve walldefining an elongate tapered cavity, wherein the elongate tapered cavitydefines a handle coupling region, a bend region, a suction headreceiving region; and a first clearance region; and a suction headdefining a suction head bore, a distal suction head end face and anoutput aperture; a handle includes a sleeve coupler and a suctionconnector barb, the handle defining an elongate cavity, the sleevecoupler defining a handle opening, the elongate cavity in fluidcommunication with the handle opening and the suction connector barb;and a hollow tubular member includes a flared end, a proximal tubularend and a bend disposed between the flared end and the proximal tubularend, the flared end extending from the output aperture, the proximaltubular end extending from the sleeve coupler, wherein a first clearancedistance normal to distal suction head end face is present in the firstclearance region when sleeve coupler is disposed in the handle couplingregion.

In one embodiment of the aspirator, the first clearance ranges from0.080 inches to about 0.11 inches. In one embodiment of the aspirator,the elongate tapered cavity defines a second clearance region, wherein asecond clearance distance normal to surface of tubular member is presentin the second clearance region when sleeve coupler is disposed in thehandle coupling region. In one embodiment of the aspirator, the secondclearance region is disposed between the first clearance region and thebend region. In one embodiment of the aspirator, the second clearanceranges from about 0.001 inches to about 0.020 inches.

In one embodiment of the aspirator, the elastic sleeve has a firstlongitudinal axis and a portion of the tubular member after the bend hasa second longitudinal axis, wherein the skewing angle between the firstlongitudinal axis and the second longitudinal axis is greater than about2 degrees and less than about 10 degrees. In one embodiment of theaspirator, the first clearance ranges from about 0.005 inches to about0.100 inches. In one embodiment of the aspirator, combination of elasticsleeve, suction head, hollow tubular member and sleeve coupler resemblesa Poole suction device.

In part, the disclosure relates to a method. The method includesproviding an aspirator includes a sleeve mount and a tubular memberextending therefrom, the tubular member includes a bend; providing anelastic sleeve defining an opening, an inner sleeve wall and a lumen toreceive the sleeve mount and tubular member; and skewing the elasticsleeve relative to a portion of the tubular member distal to the bend bya skewing angle greater than 2 degrees after sleeve mount is installedwithin the lumen. In one embodiment, a distal end of the tubular memberterminates in a suction head includes a distal end face, and may alsoinclude maintaining a clearance between the distal end face and theinner sleeve wall. In one embodiment, the clearance is less than orequal to about 0.11 inches. In one embodiment, the method is a method toprovide tactile feedback to and end user and ease assembly of sleeve andsleeve mount. In one embodiment, the method is a method of assembling asuction device.

Additional Embodiments and Features

In one embodiment, the aspirators and aspirator components describedherein comprise a polymer. In one embodiment, the aspirators andaspirator components described herein comprise a metal. In oneembodiment, the aspirators and aspirator components described hereincomprise a polymer and a metal. In one embodiment, the sleeves describedherein comprise and elastic material. In one embodiment, an aspirator asdescribed herein includes a tubular member or tube such as a cannula.The tubular member can comprise a metal. In one embodiment, an aspiratoras described herein includes metal suction head. In one embodiment, anaspirator as described herein includes a polymer suction head. In oneembodiment, the aspirators described herein comprise a tubular memberthat includes a flared end having a flared outer diameter and an innerdiameter and an end having a circular cross-section with an outerdiameter less than the flared outer diameter. In one embodiment, thetube, the aspirator, and the sleeve are manufactured using one or morepolymers.

Although, the invention relates to different aspects and embodiments, itis understood that the different aspects and embodiments disclosedherein can be integrated together as a whole or in part, as appropriate.Thus, each embodiment disclosed herein can be incorporated in each ofthe aspects to varying degrees as appropriate for a givenimplementation. Further, the various aspirators, sleeves, components,and parts of the foregoing can be used for medical applications andother applications for fluid suction and fluid delivery withoutlimitation.

Other features and advantages of the disclosed embodiments will beapparent from the following description and accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

The figures depicted and described herein are not necessarily to scale,emphasis instead generally being placed upon illustrative principles.The figures are to be considered illustrative in all aspects and are notintended to limit the invention, the scope of which is defined only bythe claims.

FIG. 1 is a side elevational view depicting an aspirator and anaspirator sleeve suitable for combination, in accordance with anillustrative embodiment of the disclosure.

FIG. 2A is a side elevational view depicting the aspirator of FIG. 1, inaccordance with an illustrative embodiment of the disclosure.

FIG. 2B is a side elevational view depicting the aspirator sleeve ofFIG. 1, in accordance with an illustrative embodiment of the disclosure.

FIG. 3 is a front view depicting an aspirator combined with an aspiratorsleeve, in accordance with an illustrative embodiment of the disclosure.

FIG. 4 is a multi-cutaway view depicting aspirator handle engagementwith an aspirator sleeve, in accordance with an illustrative embodimentof the disclosure.

FIGS. 5A, 5B, 5C and 5D are a series of multi-perspective viewsdepicting a suction head suitable for use with an aspirator and othermedical suction devices in accordance with an illustrative embodiment ofthe disclosure.

FIG. 6A is a cutaway side view depicting a distal end of an aspiratorthat includes a tubular member and suction head, in accordance with anillustrative embodiment of the disclosure.

FIG. 6B is a perspective view depicting a suction headsemi-transparently relative to a tubular member having a flared tip, inaccordance with an illustrative embodiment of the disclosure.

FIG. 6C is a side elevational view depicting a tubular member having aflared tip suitable for use with a suction head, in accordance with anillustrative embodiment of the disclosure.

FIG. 6D is a cross-section view depicting an aspirator engaging anaspirator sleeve, in accordance with an illustrative embodiment of thedisclosure.

FIG. 7A is a front view depicting an aspirator sleeve, in accordancewith an illustrative embodiment of the disclosure.

FIG. 7B is a front cutaway view depicting the suction head of theaspirator, configured to engage with the aspirator sleeve of FIG. 7A, inaccordance with an illustrative embodiment of the disclosure.

FIG. 7C is a back view depicting an aspirator sleeve and inner mattingsurface thereof, in accordance with an illustrative embodiment of thedisclosure.

FIG. 8A is a front view depicting the aspirator and aspirator sleeve,inserted into a wound or surgical incision, in accordance with anillustrative embodiment of the disclosure.

FIG. 8B is a front view depicting the suction head of an aspirator in asleeveless configuration, inserted into a wound, in accordance with anillustrative embodiment of the disclosure.

FIG. 9A is a perspective view depicting an aspirator, in accordance withan illustrative embodiment of the disclosure.

FIG. 9B is a perspective view depicting a handle of an aspirator and thesleeve coupler or mount portion thereof with a tubular member extendingfrom it, in accordance with an illustrative embodiment of thedisclosure.

FIG. 10A is a schematic view of a curve in a plane with a longitudinalaxis of rotation in the plane by which a surface or solid of revolutioncan be generated to define a flow path within a handle or other member,in accordance with an illustrative embodiment of the disclosure.

FIGS. 10B and 10C are cutaway views depicting an elongate member such asa handle that includes a fluid flow path that is suitable for use withvarious medical devices in accordance with an illustrative embodiment ofthe disclosure.

FIG. 10D is a side cutaway view depicting a suction head defining a boreattached to a flared tubular member in accordance with an illustrativeembodiment of the disclosure.

FIGS. 11A, 11B and 11C are cutaway views depicting engagement ofaspirator handle embodiments, two sleeve coupler embodiments, and sleevedeformation for each of the two coupler embodiments, in accordance withan illustrative embodiment of the disclosure.

FIGS. 12A and 12B are side cutaway views showing the engagement of anaspirator sleeve and the interference therewith over an engagementlength in accordance with an illustrative embodiment of the disclosure.

FIG. 13 is a graph depicting an overview of certain generalizedforce-engagement trends to provide context for certain design featuresrelating to an installation or combination of a sleeve with anaspirator, in accordance with an illustrative embodiment of thedisclosure.

FIGS. 14A and 14B are cutaway views depicting bending of an aspiratorafter assembly and combination with an aspirator sleeve and variousengineered clearances, in accordance with an illustrative embodiment ofthe disclosure.

FIGS. 15A, 15C and 15D are cutaway views depicting engagement of atubular member and suction head of various aspirator embodiments whileengaging with an aspirator sleeve and various axial and angularrelationships, permitted in part based on an engineered clearance, inaccordance with an illustrative embodiment of the disclosure.

FIG. 15B is a schematic representation that depicts some of the variousaxial and angular relationships of FIG. 15A without the aspirator andsleeve in accordance with an illustrative embodiment of the disclosure.

FIG. 16 is a cutaway view depicting a tubular member and suction head ofan aspirator while engaging with the aspirator sleeve, in accordancewith an illustrative embodiment of the disclosure.

FIGS. 17A and 17B are perspective views of two alternative suction headembodiments suitable for use with an aspirator and other medical suctiondevices in accordance with an illustrative embodiment of the disclosure.

DETAILED DESCRIPTION

Embodiments of an aspirator will now be described. The aspirator can beused in combination with or without an elastic sleeve in variousembodiments. Although embodiments of the present disclosure will bedepicted generally as Yankauer or Andrews aspirators, Poole suctiondevices, surgical suction catheters and other suction devices andcomponent devices thereof one skilled in the relevant art willappreciate that the disclosed embodiments are illustrative in nature,and therefore, should not be construed as limited in application or itsconstruction and mechanical and geometric properties with either aYankauer or Andrews-type aspirator, a Poole suction device, othersuction devices, other medical devices and variants of the foregoing.

The embodiments of the present disclosure have wide application, and maybe used on any similar aspirator and sleeve combination or as anaspirator without a sleeve, such as a Frazier aspirator and sleevecombination and other aspirators, surgical suction catheters, fluidtransport devices and components thereof. Some embodiments of aspiratorsand aspirator sleeve assemblies are suitable for use as disposablehandheld suction devices. The suction head described herein can be usedin any suitable suction or spraying application. Further, althoughgenerally described in the context of surgical procedures and medicaldevices, in part, the devices and methods described herein alsogenerally relate to fluid transport and suction devices and thus haveapplications outside of the medical field as such devices can be adaptedor configured, whole or in part.

Accordingly, the following descriptions and illustrations herein shouldbe considered illustrative in nature, and not limiting the scope of theinvention, as claimed. As used herein, fluid such as in fluidcommunication refers to flow paths for liquids, gases and othermaterials entrained therein which can flow through the aspiratorsdescribed herein.

Introduction to Design Features of Various Embodiments

In part, the disclosure includes features that relate to an aspiratorhaving a suction head that can be used with or without sleeve andvarious improvements relating to components of the aspirator and thecombination of the sleeve with the aspirator. In one embodiment, thesleeve is sized and configured to manually engage a handle member andalso secure to the handle and remain secured during use of thehandle-sleeve combination. Thus, in part, the disclosure relates toimproving the process of fitting a sleeve onto a handle when convertinga first handheld suction device into a combination suction device viathe installation of a flexible sleeve. In one embodiment, the assemblyprocess of engaging and securing a sleeve and a handheld member convertsa first suction device to a Poole suction device or a variation of aPoole suction device.

In one embodiment, installing a sleeve on a handle member is designed toprovide tactile feedback to the user and result in a graduallyincreasing engagement and securement rather than negligible or zeroengagement initially followed by an abrupt engagement and securement asthe end of the engagement length. The sleeve mating area handle issubstantially cylindrical in one embodiment. The method of installationincludes fitting a sleeve over a handle surface such as a sleeve coupleror sleeve mount that has a substantially cylindrical shape.

As a result, interference between sleeve and sleeve coupler of handleoccurs upon engagement and continues as sleeve moves along engagementlength of sleeve coupler. The substantially cylindrical shape isselected to avoid a conical shape and other undesirable sleeve couplershapes. In general, the undesirable sleeve coupler shapes result in anabrupt force increase during the final steps of the sleeve and handlecombination process which is undesirable to an end user.

In one embodiment, the nominal interference of the sleeve to the matingdiameter of sleeve coupler ranges from about 0.010 to about 0.020inches. In one embodiment, the nominal interference of the sleeve to themating diameter of sleeve coupler ranges from about 0.012 to about 0.040inches as another embodiment. Prior to engagement of sleeve and sleevecoupler, and the associated interference between the two duringassembly, it is worthwhile to consider the engineering of theinterference for its tactile feedback and other advantages. In part,such interference is defined by the geometry of both the sleeve and thehandle mating areas in their relaxed, never-assembled states. Theengagement length, which includes the mating length, for variousaspirator designs, such as without limitation, the designs shown anddescribed herein, ranges from about 0.400 to about 0.800 inches. In oneembodiment, the elastic sleeve includes an elastic vinyl or otherelastic polymer suitable for use in a medical application. In oneembodiment, the substantially cylindrical sleeve mount/coupler includesa rigid plastic. Other rigid polymer-based materials and other rigidmaterials can be used in various embodiments.

In addition, in one embodiment, whether a suction device is used aloneor in combination with a sleeve, the suction devices are configured toinclude improvements while retaining familiar shapes reminiscent ofclassic suction instrument designs. In one embodiment, when installingan elastic sleeve relative to or on a sleeve coupler of the handle of asuction device, the elastic sleeve conforms to the curvilinear profileof the tubular member and takes on the appearance of a Poole suctiondevice.

The shape, sizes, groove and other features of the elastic sleeve andthe handles, tubular members and suction heads and the associated bendsand contours or lack thereof for each of the foregoing described anddepicted herein can vary such that the appearance and functionalitythereof are adapted to a particular application. In addition, theshapes, sizes, grooves and other features of a given sleeve andaspirator can be tailored to replicate those of existing medical deviceswhile incorporating one or more of the various design improvementsdescribed herein.

In some configurations a sleeve is not used with an aspirator and theaspirator is used as a medical suction catheter with handle, a cannulaor tubular member, and a suction head. An exemplary suction headincludes a primary opening and a plurality of protuberances arrangedrelative thereto. A plurality of vent holes is defined by the suctionhead and arranged relative to the primary opening in one embodiment. Inaddition, a plurality of protuberances is arranged relative to the ventholes in a cantilevered configuration relative to the body of thesuction head and disposed in a geometric pattern such as a symmetricpattern relative to the primary opening. The suction head embodimentscan be used as a component of an aspirator as described herein. Inaddition, the suction head embodiments can be used with any suitablemedical device to provide suction, irrigation, or any other fluiddirecting functionality.

The suction head includes a body such as a housing or workpiece and canbe of various shapes and includes smooth surfaces that define holes,cavities, ridges, or other suction head structures or voids. The suctionhead can include one or more protrusions to help prevent obstruction ofa fluid transport channel or port of the suction head.

In one embodiment, the suction devices described herein include ahandle, a tube, a crowned or cruciform suction head, and a sleeve. Eachof the respect foregoing components of a suction device can bemanufactured using polymers, metals, resins, laminates, printablematerials and combinations and variations of the foregoing. In oneembodiment, two or more of the foregoing components of a suction deviceare unitary.

In various depictions of embodiments in the figures, a distal directionD and a proximal direction P are shown with arrows to provide areference frame. Additional details relating to these exemplaryembodiments and various other embodiments are described in more detailherein.

Aspirator, Sleeve and Combination Suction Device Features

FIGS. 1 and 2A show an aspirator 13. An elastic sleeve 40 suitable foruse with the aspirator 13 is shown in FIGS. 1 and 2B. The aspirator 13can be introduced into a sleeve 40 to form the surgical aspirator andsleeve combination 30 as shown in FIG. 3. The sleeve 40 is flexible andincludes an inner surface sized to mate with a sleeve coupler 26, whichis a portion of handle 20. The sleeve coupler 26 is the portion of thehandle to which the sleeve attaches. The sleeve 40 and sleeve couplerinterfere upon the start of engagement when the sleeve facing end facecross the plane of the proximal end face of sleeve 40 a.

In one embodiment, the handle is a body that includes a hollow or cavitythat spans the length of the handle and is in fluid communication with aproximal handle opening and a distal handle opening. This cavity of thehandle is formed from one or more cavities in one embodiment which forma fluid transport path or channel. A tubular member 14 is attached to asuction head 18. The combination of sleeve 40 and aspirator 13 isreferred to as a suction set or a combination suction device 30 in oneembodiment. The term suction catheter generally refers to an aspiratorwhich can include a sleeve or be sleeveless in various embodiments.

FIG. 2A depicts the surgical aspirator 13. The aspirator 13 generallyincludes a hollow tubular member 14 that is inserted into a wound,bodily orifice, or surgical site. Still referring to FIGS. 1 and 2A, theaspirator 13 further includes an enlarged hollow medial section, orelongated handle member 20. The handle member 20 includes a grip member22 for gripping the aspirator 13, a barb or suction tube coupling member24 that is used to attach the aspirator 13 to a tube that in turn isconnected to a source of suction (not shown), a sleeve coupler 26 forattaching a sleeve 40 (see FIG. 1) to the aspirator 13. The sleevecoupler can also be referred to as a sleeve mount or as a male couplingportion of handle.

In one embodiment, the sleeve coupler is configured as a male couplerwhich is introduced into the lumen of the sleeve at the sleeve openingbut other coupling designs are possible. In one embodiment, interferencebetween sleeve and sleeve coupler occurs upon engagement of the sleevewith the substantially cylindrical shape of the sleeve coupler. In oneembodiment, the sleeve coupler receives and interferes with the innersurface of the sleeve along an engagement length. Sleeve coupler 26extends distally from handle 20 and terminates at a sleeve coupler endface. In one embodiment, a shoulder 37 is also a component or portion ofthe handle 20. The shoulder extends beyond, surrounds the sleevecoupler, and provides a surface for the sleeve to abut when combinationwith the aspirator is complete.

The handle member 20 and tubular member 14 are constructed from one ormore materials. The materials are a rigid or semi-rigid, resilientlydeformable material that is adaptable for use in the medical arts. Inone embodiment, polymeric or resinous plastic is used. In oneembodiment, a metal is used. Suitable metals can include stainlesssteel, nickel plated brass, steel alloys, brass alloys, nickel allows,and any other metal or combinations or alloys of metal suitable for agiven medical use or having desirable mechanical properties. The tubularmember 14 can include without limitation a tube, a cannula, a tubularmember, a ferrule, and other elongate objects and combinations thereof.

The tubular member includes one or more bends 17 in one embodiment. Anynumber of combinations of bends 17 can be formed along the length oftubular member 14. The one or more bends 17 can include one or morekinks, elbows, corners, and other bends and directional changes in thetubular member. In one embodiment, the one or more bends are disposedbetween the handle and the suction head. Each bend 17 can vary over anyangle range as is desirable for a given aspirator application. In oneembodiment, the bend is absent or slight such that the tubular member 14is substantially straight.

As shown in FIGS. 1 and 2A, for example, a suction head 18 is disposedat the end of the tubular member 14 in various embodiments. The suctionhead embodiments described herein such as suction head 18 and othergeneralized embodiments in which a suction head 180 is shown are notlimited to a particular suction device, sleeve, handle or tubular butcan be used as part of any fluid transport medical device withoutlimitation.

The sleeve coupler 26 can have a continuous smooth or patterned surfaceor it can be formed from ridges or plates or subsections such that gapsand grooves are present in its surface. In one embodiment, sleevealignment grooves 56 may be formed on the sleeve coupler 26. The sleevealignment grooves 56 are formed in the proximal end of the sleevecoupler 26, and extend a predetermined distance toward the distal end ofthe sleeve coupler 26. The sleeve alignment grooves 56 are formed onopposite sides of the sleeve coupler 26. The sleeve alignment grooves 56may have any cross-sectional shape, but preferably have across-sectional shape that is generally U-shaped, V-shaped, W-shaped,X-shaped, arcuate or other suitable groove shape without limitation. Insome embodiments, no such grooves are present. The outside surface 28has a cross-sectional profile.

In one embodiment, the cross-sectional profile is substantiallycylindrical. This cross-sectional profile extends between the shoulderof the handle and the end face of the sleeve coupler in one embodimentsuch that the sleeve coupler has a substantially cylindrical shape. Inone embodiment, the sleeve and handle are designed such that a portionof the sleeve fits within a portion of the handle. In one embodiment,the sleeve and handle are designed such that the sleeve is secured tothe handle by a clasp or another securing device. In one embodiment, thehandle includes an annular fence such that the sleeve fits in betweenthe inner and outer fence sections of such a fence or is otherwiseattached thereto. Typically, the use of a substantially cylindricalsleeve mount or coupler is preferred for receiving an elastic sleeve.

Referring to FIG. 2B, the sleeve 40 may include grooves or ridges alongits external surface as desired to aid in attaching or removing thesleeve 40. In one embodiment, the sleeve includes one or more bearingflats on its interior surface. These flats are configured to align ortrack with the geometry of the suction head or any disks or other bodiesdisposed or suspended relative to the tubular member 14. In variousembodiments, bearing flats are not used. In one embodiment, the sleeveexterior surface includes ridges 47 and 52 that extend longitudinallyalong the length of the sleeve 40 on both the upper and lower surfacesof the sleeve 40.

In one embodiment, two center ridges 47 are formed proximally to oneanother along the center of both the upper and lower surfaces of thesleeve 40, wherein such center ridges 47 are disposed between twolateral ridges 52. In FIG. 7A, a dotted region 80 is shown. This region80 is an exemplary location where an optional contact feature can beincorporated in the sleeve 40 or where the sleeve itself providescontact. The contact feature, in most cases, is the inside of thesleeve. In various embodiments, region 80 is simply the inner surface ofthe sleeve. In one embodiment, the regions 80 are where the lobes of thesuction touch the inner surface. The region 80 follows the inner,natural contour of the sleeve.

In one embodiment, the sleeve 40 may include additional ribs, ridges,and other projections as well as grooves and depressions on the sleeveexterior surface to lend structural support and aid in conducting gases,fluids, and materials into the interior of the sleeve 40. The sleeve hasan inner surface, which can mate, or couple with member 26 at finalposition 43 as shown in FIG. 4. The sleeve coupler 26 enters the volumeor lumen of the sleeve V and thereby interferes with the inner wall ofthe sleeve.

In this way, the sleeve end face 40 a contacts or is in close proximitywith shoulder 37 such that engagement stops at final position 43. Thesleeve is stopped from advancing further along the member 26 because ofshoulder 37 in one embodiment. In some embodiments, such as a sleevecoupler with a conical profile the sleeve can get stuck before reachingthe shoulder 37. As a result, a substantially cylindrical profile forsleeve couplers is preferred in various embodiments. The edge of theshoulder 37 completely or partially extends around the border of member26 in various embodiments. The sleeve coupler 26 is in relief relativeto the shoulder 37 of the handle.

In one embodiment, the shoulder effectively operates as a break thatterminates movement of a sleeve when being combined with a handle viamember 26 that has a substantially cylindrical configuration. In otherconfigurations, such as when member 26 is designed to have a conicalconfiguration, the increasing force resulting from the delayed onset ofinterference during the sleeve-handle combination process often resultsin the sleeve becoming stuck along a length of the conical sleeve mount.As a result, for a conical sleeve mount, the shoulder often does notcontact the sleeve after combing a sleeve with a handle. In a preferredembodiment, when sleeve is fully engaged on sleeve coupler and contactsthe shoulder, this provides tactile feedback to user to indicate thatassembly is complete.

As shown in FIG. 2B, the sleeve 40 includes an elongate, nominallystraight sleeve tubular body that defines an internal channel having anopen, proximal sleeve end face 43 and an enclosed distal sleeve endportion 45. The end face 43 includes or is bounded by a lip or rim ofthe sleeve 40 in one embodiment. End face 43 of the sleeve includes anannular band or rim, which bounds the inner surface and lumen of thesleeve. The lip of the sleeve abuts the shoulder, which presents furthersleeve movement during installation on the aspirator. The sleeve definesa volume or lumen of the sleeve V that facilitates fluid transport andengagement with the sleeve coupler 26 at the inner sleeve wall.

The sleeve 40 also contains a plurality of spaced orifices or vent holes62 that allow gases, fluids, and materials to flow into the interior ofthe sleeve 40. The orifices or vent holes are defined by the material(s)of which the sleeve is made. The orifices or vent holes can includeholes, channels, cavities and other voids or bores that allow fluids tobe suctioned or expelled relative thereto. The orifices 62 arepreferably round or ovoid but other shapes may be used. In oneembodiment, the orifices are opening, hole, aperture, slot, slit, cleftor channel.

In one embodiment, the orifices or vent holes 62 are sized to permit theinflow of gases, fluids, and materials of a size that will not clog theopening 16 in the tubular member 14 (e.g., a suction head 18) when thetubular member is enclosed by the sleeve 40. Larger materials, on theother hand, such as body tissue, are unable to pass through the orifices62 and may clog them. The suction head 18 is configured to preventclogging when used without a sleeve in some embodiments through itsvarious protuberances 17. In one embodiment, the suction head has abulbous geometry that includes two or more groupings of symmetricfeatures defined by the material used to form the suction head 18.

In one embodiment, the orifices or vent holes 62 are formed between thecenter ridges 47 and the lateral ridges 52 on each side of the sleeve 40so that the ridges 47 and 52 may engage the tissue and form a gapbetween the tissue and the orifices or vent holes 62, thereby preventingclogging. The orifices 62 on one side of sleeve 40 are in alignment withorifices or vent holes 62 on the opposite side of the sleeve.

The sleeve 40 is preferably constructed from a material suitablyflexible to conform to the shape of tubular member 14 inserted thereinand bend as sleeve 40 engages with coupler 26 of the handle. Suitablematerials to construct the sleeve include rigid or semi-rigid,resiliently deformable materials adaptable for use in the medical artssuch as polymeric or resinous plastic or other elastic materials.Alternatively, the sleeve 40 may instead be contoured to match thecontours present in the tubular member 14.

Referring back to FIG. 2A, the sleeve coupler 26 includes an outsidesurface 28. The sleeve coupler 26 may be formed in the distal portion ofthe handle member 20 or attached to the handle member 20 as a separatecomponent. Alternatively, the sleeve coupler 26 may be attached to thetubular member 14 and not attached to the handle member 20. In a oneembodiment, the sleeve coupler 26 is between about 20 and about 70 mmlong in the longitudinal direction. In one embodiment, the sleevecoupler 26 is substantially cylindrical.

Additional details relating to an exemplary substantially cylindricalcoupling member 260 and a non-cylindrical member 265, which is a conicalmember in this example, are shown in FIGS. 11A and 11B and described infurther detail below. The associated deforming effects of such memberson a sleeves 1200, 1205 are shown in FIGS. 11A and 11C with regard tosleeve 1205 (engagement with substantially non-cylindrical/conicalsleeve mount 265) compared relative to sleeve 1200 (engagement withsubstantially cylindrical sleeve mount 260). The left side of FIGS.11A-11C show a combined sleeve and sleeve coupler, a sleeve coupler anda deformed sleeve for a sleeve coupler 260 having a substantiallycylindrical profile. The right side of FIGS. 11A-11C show a combinedsleeve and sleeve coupler, a sleeve coupler and a deformed sleeve for asleeve coupler 265 having a conical profile.

In one embodiment, the coupling member 26 has a substantiallycylindrical shape and generally has the same cross-section orsubstantially the same cross-section along its longitudinal axis.Although some slight tapering is permitted. In one embodiment, thedegree of tapering of a substantially cylindrical object of thedisclosure has an angle of taper of less than about three degreesmeasured relative to the longitudinal axis of the object. In oneembodiment, the angle of taper is less than about 2 degrees measuredrelative to the longitudinal axis of the object.

In alternate embodiments, the cross-sectional areas of the proximal anddistal ends may be approximately equal (e.g., substantially cylindricalconfiguration). In a preferred embodiment, along its lateral axis, thecross-sectional diameter of the proximal end of the sleeve coupler 26 isbetween about 4 and about 20 mm and the cross-sectional diameter of thedistal end is between about 4 and about 20 mm. The cross-sectional areaof the proximal end sleeve coupler 26 is preferably less than thecross-sectional area of the distal end of the grip member 22.

In one embodiment, substantially cylindrical, in the context ofinterference fit of an elastic sleeve and sleeve coupling member meansthat the fit (e.g., fit between the handle member 20 and the sleeve 40)mechanically behaves as if the mating surfaces are approximatelycylindrical. As used herein, the term “substantially cylindrical” meansgenerally having the shape of a cylinder or a cylindrical shape suchthat the object resembles a cylinder, but can have one or moredeviations from a true cylinder, either with or without a contour, asexplained herein.

As reference frame, the cylinder or cylindrical shape of sleeve coupler26 can include a longitudinal axis. In one embodiment, the deviationsfrom a true cylinder are in the radial direction and can vary along thelongitudinal axis. In addition, due to manufacturing constraints, theremay be a conical taper to the surfaces that are herein referred to assubstantially cylindrical as described herein and may be constrained byangle of taper or a draft angle. In one embodiment, the draft angle fora substantially cylindrical object is greater than zero and less thanabout 3 degrees. In one embodiment, the angle by which the substantiallycylindrical object tapers relative to a longitudinal axis thereof rangesfrom greater than about 0 degrees to about 3 degrees. In one embodiment,a substantially cylindrical sleeve coupler is a sleeve coupler thatavoids the assembly force profile of a conical or substantially conicalsleeve coupler as described herein.

The cross-sectional shape of the sleeve coupler 26 may remain constantor vary (as depicted in FIG. 2A) along the longitudinal axis withincertain thresholds. In one embodiment, the draft angle of the sleevecoupler is less than or equal to about 4 degrees. The sleeve coupler 26,excluding longitudinal exterior grooves 74 (described below), may haveany cross-sectional shape, but preferably has a cross-sectional shapethat is substantially cylindrical. The sleeve coupler can have across-sectional shape that is generally round, ovoid, square,rectangular, triangular, hexagonal, or other closed shape.

Still referring to FIG. 2A, handle member 20 includes at least onelongitudinal exterior groove 74 extending longitudinally along theoutside surface of handle member 20. In one embodiment, longitudinalexterior grooves 74 extend from the proximal to the distal end of sleevecoupler 26. It is appreciated that the grooves 74 may extend from theproximal end of the sleeve coupler 26 and along only a portion of thesleeve coupler 26. In addition, the longitudinal exterior grooves 74extend onto a section of the grip member 22 from its distal end.Alternatively, separate grooves may be included in the grip member 22that are in communication or intersect with longitudinal exteriorgrooves 74 on the sleeve coupler 26. Preferably, longitudinal exteriorgrooves 74 are between about 1 and about 7 mm deep and about 1 and about10 mm wide, and have any cross-sectional shape such as U-shaped,V-shaped, M-shaped, or other suitable groove shape.

The longitudinal grooves 74 may extend along the entire length of thegrip member 22, or, alternatively, may extend along only a portion ofthe grip member 22. Referring to FIG. 2A, a first set 75 of longitudinalgrooves 74 are preferably formed along the top of the grip member 22 anda second set 77 of longitudinal grooves 74 are formed along the bottomof the grip member 22. Each set of longitudinal grooves 75 and 77 isshown having three longitudinal exterior grooves 74; however, fewer ormore than three grooves 74 may instead be used. The first set 75 oflongitudinal grooves preferably extend along only a portion of the gripmember 22, and the second set 77 of longitudinal grooves preferablyextend along the entire length of the grip member 22.

As shown in FIG. 2A, the grip member 22 of the handle 20 may alsoinclude a lateral groove 76 formed along each side of the grip member 22lateral to the longitudinal exterior grooves 74. The lateral grooves 76may extend along the entire length of the grip member 22 or only aportion thereof. The lateral grooves 76 provide traction on the gripmember 22 to aid in holding the grip member, especially when attachingor removing the sleeve 40.

Still referring to FIG. 2A, the grip member 22 is suitably sized to bereceived into an average sized hand but larger or smaller grip sectionsmay be constructed for larger or smaller hands respectively. When beingheld in a typical manner by a user, the top side of the grip member 22can be engaged with a user's thumb, and the bottom side of the gripmember 22 is can be engaged with the remaining fingers. FIG. 1, forexample, illustrates a typical manner of holding the grip member 22 by auser. However, it should be appreciated that the grip member 22 may beheld in any comfortable, effective manner.

For instance, the user may instead wrap his entire hand around the gripmember 22 such that the user's fingers engage the top side of the gripmember 22. Generally, the grip member 22 may be between about 35 and 80mm long and have a cross-sectional width between about 12 and about 30mm and a cross-sectional height between about 12 and about 30 mm. Thegrip member 22 may also be tapered or include contours along itslongitudinal axis for a more comfortable grip.

In one embodiment depicted in FIG. 3, the combination of an exemplaryembodiment of a sleeve 40 combined with a handle member 20 is shown ascombination suction device 30. As shown a substantially cylindricalsleeve coupler 26 of handle 20 is disposed within sleeve 40. In oneembodiment the device 30 is designed to resemble a Poole suction devicewith the bending of the sleeve being reduced such the sleeve isstraightened to the extent possible. With regard to the device 30 shown,the installation of the sleeve 40 is achieved by engaging the sleeve'sinner surface with a substantially cylindrical mating region of thehandle member.

In further detail, the distal end of the grip member 22 abuts theproximal end of the sleeve coupler 42 of the sleeve 40. Longitudinalexterior grooves extend onto grip member 22 from the distal end. Airflows through the portion of longitudinal exterior grooves located inhandle member 22 into venting channels. This configuration may preventair flow interference by either the hand of the user or the distal endof the grip member 22; air can freely flow through the venting channels.

With the sleeve 40 in place, the distal end of the aspirator 13 andsleeve 40 combination device 30 may be inserted into the wound, surgicalsite, or bodily orifice to remove fluids therein. Suction flows from thesuction source, such as a suction pump, through a tube and into thehandle member 20 (as shown in FIG. 1). The suction head (not shown)provides suction within the sleeve 40 which pulls liquid in through thevarious orifices of the sleeve. As shown in FIG. 2A, the barb or suctiontube coupling member 24 may include a tiered section that is coupled tothe tube and associated suction source by inserting one or more of thetiers having a smaller cross-sectional area into the tube. Generally,any tube coupling mechanism may be used. The tube may be constructedfrom any tubular material suitable for transmitting suction forces to asurgical aspirator and gases, fluids and materials from a surgical siteknown in the medical arts.

Handle member 20 defines one or more bores therein (not shown in FIG.3). In one embodiment, the bores are in stacked arrangement of segmentsof varying lengths and diameters to define a fluid flow path or channel.The cavity within the handle 20 can be defined as a surface of rotationas described in more detail below. For example, the curve 175 a in FIG.10A can be rotated relative to a longitudinal axis L_(axis) such thatthe fluid flow path or cavity 175 b of FIG. 10B is defined. In oneembodiment, the arrangement of segments resembles the adjacent sectionsof a telescope with the diameter of the smaller segment being sized tofit within the larger diameter of the adjoining section. These boresegments or elongate cavities are in fluid communication with suctiontube coupling member 24 and suction head 18 in various embodiments.Additional details relating to this arrangement of elongate cavitysections to form fluid transport channels are discussed with regard toFIGS. 10A, 10B and 10C.

In addition, further details relating to the suction head and theseelongate cavity sections including the interface of the suction headbore 110 d, flared tube end, bore segment disposed in handle, suctionconnector bore, and a transitional flow cavity in between the suctionconnector bore and the tube bore, and suction head housing is shown inFIGS. 10B, 10C and 10D. FIG. 10D is a side cutaway view depicting asuction head defining a bore attached to a flared tubular member inaccordance with an illustrative embodiment of the disclosure.

Suction traverses the handle member 20 and into the tubular member 14.In various embodiments, the suction traverses the stepped or tieredarrangement of cavities in handle 20. Suction travels up the tubularmember and pulls gases, fluids, and small materials into the opening 16.The gases, fluids, and materials inside the sleeve 40 flow from thewound, surgical site, or bodily orifice into the sleeve 40 through theplurality of orifices 62 and opening 16. If the orifices 62 becomeclogged, such that the flow of gases, fluids, and materials into theinterior of the sleeve 40 is at least partially restricted, air flow isavailable to the sleeve through the venting channels. Air provided bythe venting channels may prevent uneven distribution of suction forcesover any unclogged orifices 62. Otherwise, if the suction force isconcentrated over too few orifices 62, the tissue surrounding the woundcould be pulled into the orifices 62 in the sleeve 40 causingdiscomfort, pain, and injury to the patient.

Engagement Between Surgical Aspirator Handle and Sleeve

Referring now to FIGS. 3 and 4, the sleeve 40 slides over the tubularmember 14 of the aspirator 13 so that the tubular member 14 is encasedby the sleeve 40. Generally, the sleeve 40 is attached to the aspirator13 at the handle member 20 by a coupling device. The coupling deviceincludes a sleeve coupling member such as the sleeve coupler 26, shownin FIGS. 2A, 4 and 11A and 11B, and a sleeve coupling member such as thesleeve coupler. The sleeve coupler 26 is received into the proximal endface of the sleeve, which has an inner lumen or receiving volume V toreceive the suction head and tubular next member.

As shown in FIG. 3, a coupled region 70 is formed where the sleevecoupler 26 is inserted into the sleeve coupler 26 and span an engagementlength EL along the coupler 26. In one embodiment, the sleeve 40 and thesleeve coupler 26 of the handle are designed such that interferencecommences as soon as the outer surface of the sleeve coupler 26 entersthe cavity of the sleeve 40 or otherwise is aligned with and initiallycontacts the inner wall or rim of the sleeve 40. As depicted in FIG. 4,the sleeve 40 is attached to the handle member 20 at the proximal sleeveend face 43 of the sleeve 40. Likewise, the sleeve 40 may include aplurality of orifices 62.

In one embodiment, members 26 and 40 couple or engage together such thatthe elastic sleeve grips and expands to a substantially cylindricalcoupler 26 as the sleeve 40 and sleeve coupler 26 of the handleinterfere over an engagement length of the coupler. These features areshown in FIG. 3, on the left side of FIGS. 11A-11C, respectively and inFIGS. 12A and 12B. This process of installing the sleeve relative to thehandle's coupling or mounting member provides tactile feedback to an enduser without abrupt changes in the installation force profile as shownin FIG. 13. This has the advantage of allowing an end user to securelycouple the sleeve and the aspirator as they move relative to each otherover a distance. This overcomes certain disadvantages with a conicalprofile.

In general, a conical profile is an example of a non-cylindricalprofile. A conical profile of a sleeve mating or couple member 26 can beused in some embodiments, but this design has various design limitationsthat can be overcome using a substantially cylindrical profile. Thesecan be seen on the embodiments on the rights side of FIGS. 11A-11C forcoupler 265. Specifically, with a non-substantially cylindrical coupler,an abrupt spike or increase in the force needed to secure a sleeve to aconical member occurs during engagement and is jarring to the touch.Further, the force needed to achieve the majority of the frictionfitting over the remaining short coupling distance consistent withcoupling a sleeve to a conical member, may exceed the hand strength ofvarious end users.

In contrast, as disclosed herein pairing of an elastic sleeve with asubstantially cylindrical coupling member of an aspirator requires lesshand strength to complete the friction fit of the sleeve onto the handleand the tactile experience during the combination is gradual and lessjarring than in the case of a conical member to sleeve coupling. As aresult, substantially cylindrically shaped sleeve couplers, such ascouplers 26, 260 are preferred in one embodiment. As a related pointwith regard to the assembly of the elastic sleeve relative to the handleover the sleeve coupler, there is hysteresis in the sleeve. Although thesleeve is not being plastically deformed during assembly, theinterference with the sleeve mount over an engagement distance canchange the shape of the sleeve. Accordingly, after assembly and removal,the sleeve does not necessarily return to its as-molded state.

As shown in FIGS. 5A-5D, an enlarged suction head 180, open at itsdistal end, is formed on the distal end of the tubular member 14. Thesuction head 18 includes a body or housing 27. The suction head 180defines a distal opening or orifice 16 into which gases, fluids, andmaterials can flow. The suction head has a protective role in variousembodiments and generally includes smooth surfaces to avoid cutting orotherwise damaging tissue. In general, smooth or non-sharp surfaces andsurface contours and transitions are used in a given aspirator andsleeve design.

The suction head 180 includes one or more flow maintaining features toavoid tissue damage under various suction scenarios by pushing tissueout of the way to maintain flow to opening 16 or other vent holes in thesuction head 180. In one embodiment, the housing is made from a polymer,metal, glass, or other material. The housing is formed by injectionmolding in one embodiment. The body of the suction head is unitary inone embodiment. Other manufacturing processes can be used in variousembodiments. In one embodiment, tubular member includes a flared endthat the suction head surrounds. This can be achieved via a printing ormolding process or a dip and ablate process in one embodiment.

In one embodiment, the housing tapers to a substantially elliptical endopening 16, the substantially elliptical opening defined by the housingand in fluid communication with the central bore. The substantiallyelliptical end opening can be a circle or substantially circular in oneembodiment. With regard to the various embodiments disclosed herein, ataper can be a curvilinear taper, a straight taper, or combinations ofdiffering taper configurations. In one embodiment, the suction head hasa shape corresponding to the revolution of a curve about a longitudinalaxis as shown in FIG. 10A and described herein. In one embodiment, thesuction head has a shape such as for example a cross-sectional shapethat includes one or more of the following shapes: a tear, a pear, anelliptical shape, a spherical shape, a hemispherical shape, a conicalshape, others shape that lacks sharp edges, an organic shape similar tothe forgoing and combinations of the foregoing and subsets thereof.

In one embodiment, the suction head 180 includes protuberances 17 thatare disposed on, extend from, or otherwise part of the suction head 180.The protuberances are arranged relative to an end face of the suctionhead such as a rim or annular band that surround opening 16. Varioustypes of protuberances 17 can be incorporated into the suction head tomaintain one or more fluid flow paths even in the event of tissue orother material blocking other flow paths into opening 16. In oneembodiment, the suction head includes a plurality or protuberances thatare cantilevered from the forward face of the suction head. This forwardface is also referred to herein as a distal end face and includes therim or lip of the central opening 16. In one embodiment, eachprotuberance can include various surfaces, regions, or ends. In oneembodiment, the distal end of each protuberance extends beyond thecentral opening a distance D. D ranges from about 0.002 inches to about0.1 inches in one embodiment.

In one embodiment, the protuberances 17 form suction head grooves 21there between. The suction head 180 is preferably formed with two orfour suction protuberances 17 such as ridges that are generally the samesize and shape and equidistant from one another, each ridge 17 beingdiametrically opposite another ridge 17. The suction head ridges areused to abut the sleeve 40 to form a gap between the suction head 180and the sleeve 40. However, if the aspirator 13 is used without thesleeve 40, the suction head protuberances 17 are capable of bridging theadjacent soft tissue and maintaining the channels in the grooves 21 openfor the flow of fluid, gas, and materials through the channels.

The suction head 180 may include additional vent ports or apertures 19.The suction head apertures 19 are formed in suction head grooves 21, andeach suction head aperture 19 extends laterally through the suction headfrom a first suction head groove 21 to an adjacent suction head groove21. FIGS. 5A-5C illustrate three rows of suction head apertures 19 a-19c formed between adjacent suction head grooves 21 a and 21 c. Each rowof suction head apertures 19 a-19 c is positioned approximately parallelto the other rows. In one embodiment, the suction head apertures have acentral channel that passes all the way through the housing. The centralaxis of this channel is approximately perpendicular to the longitudinalaxis of the suction head that passes through opening 16. The suctionhead apertures 19 intersect the suction head opening 16, such that thesuction head apertures 19 are in communication with the suction headopening 16. In FIG. 5C, two protuberances are shown. In otherembodiments, three or more protuberances can be used.

In this manner, gases, fluids, and materials may flow within the grooves21, through the suction head orifices 19, and into the opening 16 in thedistal end of the tubular member 14. Although three rows of orifices areshown, it is to be understood that other numbers of rows of orifices 19,either fewer or greater in number, can be utilized. Also, the orificesare shown as round in cross-section, but the orifices can be of othercross-sectional shapes, such as oval, hexagonal, octagonal, etc.

FIGS. 17A and 17B are perspective views of two alternative suction headembodiments 186, 188. These suction head embodiments 186, 188 aresuitable for use with an aspirator and other medical suction devices inaccordance with an illustrative embodiment of the disclosure. Eachsuction head 186, 188 is attached to a tubular member 14 which caninclude one or more bends. In one embodiment, suction head 186 is formedusing plastic or other materials as described herein. In one embodiment,suction head 188 is formed by insert molding. The suction heads 186, 188include bores that terminate at a primary opening 16. Each suction headalso includes one or more surface features such as the protuberances 17shown. The protuberances 17 are cantilevered relative to the opening andradially extend around the bore. A protuberance can range from about0.002 inches to about 0.1 inches. In another embodiment, a protuberancecan range from about 0.001 inches to about 0.2 inches.

The suction heads 186, 188 include a body, which can be formed fromplastic or other materials. The body of each suction head definesvarious orifices 19. In one embodiment, the orifices 19 are formed insuction head grooves 21. In one embodiment, each suction head orifices19 extends laterally through the suction head portion from a firstsuction head groove 21 to an adjacent suction head groove 21. The open16 is surrounded by a distal end face which can be various shapes suchas a ring or annular region or an irregular or rectilinear shape.Various suction heads can be used with the aspirators described hereinand vary in size and individual dimensions based on the particularsuction device design and application thereof. The suction heads 186,188 are provided as further exemplary embodiments.

Fluid Transport and Suction Promoting Tip Embodiments

As noted herein, various embodiments of suction devices improve theperformance of suction when the surgical aspirator 13 (particularly thesuction head 18, 180) is used alone (e.g., without the sleeve 40, 1200).In addition, the various types of suction heads described herein can beused with different aspirator and other fluid flow directing deviceswithout limitation. In FIG. 6A, as a general embodiment, a bulboussuction head 190 is showed with a tubular member 140 partiallysurrounded by the suction head 190. Additional details of variousthickness associated with the flow path of the handle 200 that are influid communication with tubular member 140 are shown in FIGS. 10B and10C. Still referring to FIG. 6A, the outer diameter OD of the tubularmember 140 is also depicted herewith.

The inner diameter of the bore of tubular member 140 is shown bythickness T3. In general, the thickness of the tubular member bore T3 isthe smallest diameter thickness relative to the thickness of the suctionhead bore T4, and the thickness of the transitional cavity T2 and thethickness T1 of the proximal cavity. The transitional cavity and theproximal cavity can generally be referred to as first and second fluidflow cavities (and vice versa) in one embodiment. The flared lip or edge102 of the terminus of the tubular member is shown relative to a dottedlongitudinal axis.

In one embodiment, the inner flared edge of 102 of member 140 is flaredby an angle F relative to the longitudinal axis of the tubular member.In one embodiment, flaring angle F ranges from greater than or equal to0 to about 36 degrees in one embodiment. In one embodiment, the flaringangle F ranges from about 10 degrees to about 45 degrees. In oneembodiment, the flaring angle F ranges from about 25 degrees to about 38degrees. In one embodiment, the flaring angle F ranges from about 30degrees to about 37 degrees. The flaring angle F is selected to providean attachment site at the end of tubular member for plastic or othermaterials to form around as part of a molding process. In oneembodiment, this process is used to attach a metal tubular member havinga flared end to a suction head such that the suction head surrounds theflared end and is mechanically fastened thereto. This can be seen in thepartially transparent view of FIG. 6B in which suction head 180 hasflared end of tubular member 140 with flaring angle F disposed therein.

In addition as shown in FIG. 6A, the bore of the suction head 193 has athickness T4. The bore of the suction head 193 terminates at opening 16.The thickness of the bore 193 is greater than the tube thickness 140.The bore 193 can be defined as a surface of revolution or a revolute andhave various shapes and configurations. The bore 193 is in fluidcommunication with the elongate fluid flow path of the handle of theaspirator. With regard to FIGS. 10A and 10B, the bore 193 is in fluidcommunication with elongates sections 110 a, 110 b, and 110 c. Theelongate section 110 c defined by the handle is a proximal cavity orfluid flow cavity 110 a. This cavity can include the bore of the suctionconnector 250 bore in one embodiment.

In one embodiment, elongate cavity 110 c is defined by the inner surfaceof the tubular member 140 and is the bore of that member 140. Thistubular member bore or fluid flow cavity extends through the tubularmember 140 until it undergoes a transition when it interfaces withflared region 122 of the tubular member as shown in FIG. 10D. The flaredregion 122 is part of the suction head, which also includes a fluid flowcavity in the form of the suction head bore 110 d. The thickness T4 ofthe suction head bore 193 is selected to be greater than the thicknessof tubular member 140. In one embodiment, with respect to the zone orregion at which the flared tubular member expands into the suction head190, a radius can be defined relative to the bore 193 and the flared lip102 of the tubular member 140.

In one embodiment, the disclosure relates to a suction head thatincludes an opening and a plurality of vent holes arranged relativethereto. In one embodiment, the opening is a central or primary opening16. Such an opening is positioned relative to a distal end face and isthe widest opening, port or aperture in the suction head. The central orprimary opening is in fluid communication with a distal end face and isat least partially defined by a lip or rim. The distal end face caninclude an annular region of the suction head that bounds the primaryopening of the suction head. The suction head can include variousprotuberances 17, as shown in FIGS. 6B and 7B for example. Theprotuberances 17 can be aligned to orient with the vent holes, ridges 47and 52 and other components of the sleeve. The protuberances 17 arecantilevered relative to one or more features of the suction head 28 inone embodiment. The plurality of protuberances are disposed radiallyaround the primary opening in one embodiment. The plurality ofprotuberances is 2 in one embodiment. The plurality of protuberances is4 in one embodiment. The plurality of protuberances is one or more inone embodiment. The suction head body can include one or more lobes.

In one embodiment, one or more of the lobes is aligned with orterminates at a protuberance. Two protuberances aligned with two lobesof a suction head can be seen in the embodiment of FIG. 5C. In oneembodiment, the suction head includes two or four second-regionprotuberances and two or more lobes. In one embodiment, the top andbottom lobes have first region protuberances. The first regionprotuberances are cantilevered relative to the primary opening in oneembodiment. The second region protuberances extend outward from suctionhead such as ribs or fins in one embodiment.

In one embodiment, a pair of protuberances are aligned along a diameterof the bore of the suction head. In one embodiment, a pair of lobes ofsuction head is aligned along a diameter of the bore of the suctionhead. In one embodiment, a first pair of lobes is aligned along a firstdiameter of the bore of the suction head. In one embodiment, a secondpair of lobes is aligned along a second diameter of the bore of thesuction head. The first and second diameters can be arranged at an anglesuch as a 90 degree, 45 degree or another angle. In one embodiment, thefirst and second diameters are orthogonal such that the lobes form acruciform configuration. In one embodiment, the suction head includesfour lobes and has a cross shape, which each lobe corresponding to anarm of a cross.

In one embodiment, the suction head has a crowned feature formed from aplurality of protuberances, for example, as illustrated by the exemplarysuction head embodiments in FIGS. 5A-5D, 6A and 6B. Specifically, thecrowned suction head includes protuberances or protrusions 17 thatprevent the primary suction hole from being closed off by debris andtissues during use. The suction head 18 is bulbous and in communicationwith a tubular member such as tubular member 14. FIG. 6B shows a suctionhead 180 with the addition of a tubular member 140. As shown, the flaredportion of tubular member is potted in the suction head to form amechanical strong attachment. In one embodiment, the suction head 180 isa bulbous housing or workpiece having one or more protuberances such asthe crown or cruciform embodiments described herein.

A protuberance 17 is shown on the top of suction 180 in a cantileveredconfiguration relative to opening 16. As shown, the protuberance 17extends outward at end 177 past the end face 83 of the suction head 180.This extension of the protuberance 17 relative to end face 83 helpscreate a flow channel relative to opening 16 and tissue as describedwith regard to FIG. 8B. Effectively, a protuberance acts like a tentpole that raises the tissue surface in contact with the suction headduring a procedure. In this way, the portion of the protuberance incontact with the tissue defines at least a portion of a flow path.Absent the protuberances, the suction head would apply suction to thetissue surface and adhere to the tissue when suction is applied via thebarb.

FIG. 6C illustrates a side elevational view of an exemplary tubularmember 14. The tubular member can include various bends and curves (notshown) in an embodiment. In the embodiment illustrated in FIG. 6C, thetubular member 14 has a flared profile. The flaring angle F is shown.The inner and outer thicknesses of the unflared portion of the member 14are T3 and OD as shown. The flared end face 300 has an outer diameterODF and an inner diameter IDF.

The ratio of the outer diameter of flared end of tubular member (ODF) tothe outer diameter of the tubular member OD is less than or equal toabout 1.4. This ratio can also be represented as a fraction as ODF/OD.This ratio has been determined to be an advantageous design constraintfor various embodiments. The flared end face 300 helps lock or fastenthe suction head 18 (not shown in FIG. 6C) to the tubular member 14. Inone embodiment, the suction head is molded around end face 300.

For example, the suction head 18 may include suction head orifices 19.The suction head orifices 19 are formed in suction head grooves 21, andeach suction head orifices 19 extends laterally through the suction headportion from a first suction head groove 21 to an adjacent suction headgroove 21. The suction head protrusions 17 provide adequate spacingbetween the suction head orifices 19 on the suction head groove 21 andthe surface of the sleeve 40.

Referring to FIG. 6C, sleeve 40 may include sleeve alignment ribs 50formed along a portion of the interior surface 41 of the sleeve 40 inthe space between the orifices 62. The cross-section of fluid transportchannel or bore is disposed centrally in FIG. 6C. In region 60, fluidsor gases are flowing during operation of a combined sleeve and suctionset. The sleeve alignment ribs 50 extend from the proximal end of thesleeve 43 toward the distal tip sleeve end portion 45. Preferably, twosleeve alignment ribs 50 are formed on the interior surface of thesleeve 41 on opposite sides of the sleeve 40. The sleeve alignment ribs50 taper in height as the ribs 50 extend toward the distal tip sleeveend portion 45.

In one embodiment, the sleeve alignment ribs 50 conform or partiallyconform to the shape of the sleeve alignment grooves 56, such that thesleeve alignment grooves 56 may engage with and receive the sleevealignment ribs 50 when the sleeve 40 receives the aspirator 13, as shownin FIG. 3. The sleeve alignment ribs 50 are tapered at the proximal endof the sleeve to form lead-in portions. The lead-in portions aid insecuring the sleeve 40 to the aspirator 13 by guiding the sleevealignment ribs 50 into the sleeve alignment grooves 56.

The sleeve alignment ribs 50 engage and move relative to the sleevealignment grooves 56 so that the sleeve 40 is properly aligned andcoupled to the aspirator 13. In one embodiment, the sleeve alignmentgrooves orient the sleeve relative to the handle and metal tube and thesuction head at the end of the tube. The orientation of the suction headand ridges 17 are set with regard to the handle and thus can be orientedrelative to the alignment grooves in the handle. When mated or coupled,in one embodiment, the suction head projections align with the foursuction head protuberances or ridges 17 to form a gap between thesuction head 18 and the sleeve 40.

As discussed with regard to various embodiments, the sleeve 40 and thesleeve coupler 26 of the handle of a given aspirator embodiment aresized in a plurality of dimensions to cause interference when combinedtogether. Several zones or regions of interference 65 are shown in thefigure. They are distributed circumferentially around the inner sleevewall surface and the surface of the sleeve mount in one embodiment. Asshown, the sleeve coupler 26 has a surface that has a substantiallycylindrical profile but the surface is not continuous as a result of thegrooves or ridges used to form its structure.

FIGS. 6D and 7A-7B depict sleeve 40 engagement with the suction head 18of the sleeve 40. Additionally, cross-holes remain properly aligned withlongitudinal exterior grooves to ensure proper venting and air flow intothe sleeve 40. Moreover, when the sleeve alignment ribs 50 are receivedby and interfere with the sleeve alignment grooves 56, the sleeve 40 islocked into place and will not rotate about aspirator 13. Thus, whilethe aspirator 13 is being used, the bearing flats will remain abutted tothe four suction protuberances 17, and the cross-holes will remainproperly aligned with longitudinal exterior grooves. In FIG. 6D,alignment grooves 56 are sized with an engineered clearance relative tothe alignment ribs or tongues 50 such that the two components can alignand mate without interfering.

To further aid in proper alignment, indicator designs or indicia may beformed on the sleeve 40 and handle member 20, respectively. Preferably,the indicator designs comprise an arrow or other suitable design orindicia. For example, the indicator design may be in alignment with thecenter ridges of the sleeve 40 and be in the form of an arrow, with thearrow pointing toward the proximal end of the sleeve 40. Likewise, forexample, the indicator design may be formed on both sides of the sleeve40. A similar indicator design may be formed on the top of the gripmember 22, in alignment with the first set of longitudinal exteriorgrooves, with the arrow pointing toward the sleeve coupler 26.

Either of the two arrows on the sleeve 40 may be aligned with the arrowon the grip member 22 when inserting the aspirator 13 into the sleeve40, such that the sleeve may be rotated 180° and still properly matewith the aspirator. The indicator designs may facilitate properalignment of the sleeve alignment ribs 50 with the sleeve alignmentgrooves 56, thereby ensuring that the suction head projections alignand/or abut the four suction head ridges 17.

It should be appreciated that any suitable design or indicia may be usedto guide the insertion of the aspirator 13 into the sleeve 40. Theindicator design is formed in alignment with the first set 75 oflongitudinal grooves 74 on the top of the grip member 22 such that thefirst set 75 of longitudinal grooves extends only partially along thegrip member 22 from the distal end of the grip member 22. It should beappreciated that the indicator design may instead be formed within thefirst set of longitudinal grooves 75 such that the continuity of thelongitudinal grooves 75 is not interrupted, and the grooves 75 insteadextend along the entire length of the grip member 22 or a portionthereof.

FIG. 7C is a back view depicting a surgical aspirator sleeve 40 of FIG.7A, an exemplary sleeve alignment rib 50, and an inner matting surfacethereof 85. As described herein with regard to other embodiments, whenthe handle member engages the sleeve such that the groove on the handlemember aligns with groove 50, the contacting points C1, C2 of thesuction head shown in FIG. 7B are disposed within the lumen of thesleeve 40 or make contact with the inner sleeve wall or a featureextended therefrom. In one embodiment, mating flats or anotherprojection of the inner sleeve surface can be present at region 80.Thus, alignment at the handle with respect to the sleeve facilitatessuction head alignment. In turn, this offers advantages in terms offacilitating the aspirator and metal tube being positioned in the sleeve40 at a predetermined position or with a predetermine clearance.

In one embodiment, as shown in FIG. 7B, the suction head 180 includes abody with various protuberances 17. In one embodiment, the body includesa bore which provides a fluid transport function. The body is bulbousfluid flow directing member in one embodiment. The body can be ofvarious shapes without limitation. Further, as shown the suction headincludes an annular or ring-shaped distal end face 83 encircling orsurrounding the primary suction head opening or bore 16. To providegreater stability, in one embodiment, one or protuberances 17 arecantilevered relative to the ring-shaped distal end face 83 and disposedaround opening 16 in a symmetric or patterned arrangement.

Draft Features Relating to Suction Head Embodiments

In one embodiment, one or more of the components of a given suctiondevice are formed using a molding process such as injection molding. Forexample, in one embodiment the handle component is molded with two partsof a mold coming together. Because of the molding process, a partingline is aligned with a plane that bisects the suction handle. This lineand associated plane can effectively be seen when a witness line isvisible on the molded part. This line on some embodiments of the handleand other molded parts is referred to as a parting line. The partingline indicates the plane where the mold separates. A given molded parttypically drafts from this plane. That is, the part has a suitablepositive draft angle so that it can be removed from the mold.

In one embodiment, there is one parting line or plane that bisects thehandle 20. There is another parting line that is perpendicular to theaxis of the tube inset from the outer most set of protuberances by adistance of about 0.005 inches to about 1 inches. In one embodiment, theparting line is moved away from suction head opening 16 to reduce thepossibility of any tissue snagging because of parting line or materialarranged or extending with respect to it from the molding process. Inone embodiment, with regard to the suction head and its associated ventholes, the draft-axis of a plurality of vent holes is perpendicular tothe parting line.

Additionally, in a preferred embodiment, the parting line is not at therim of the primary opening 16. Rather, the parting line is back towardthe handle 20. By their nature, parting lines may be sharp. The locationof the parting line prevents any kind of sharp edge on the most usedsurface of the aspirator 13.

Exemplary Surgical Aspirator and Sleeve Uses

FIG. 8A depicts a surgical aspirator 13 and surgical aspirator sleeve 40that includes one or more of the features and implementations describedherein. In particular, the aspirator 13 and sleeve are shown in atypical application such as a medical procedure. For example, thesurgical aspirator 13 and surgical aspirator sleeve 40 may be assembledto form a combined suction device 30. The combined suction device 30 isinserted into a wound 800 of a patient. As shown, the substantiallystraight orientation of the device 30 causes it to resemble a Poolesuction device. An example scenario when a crown or cruciform suctionhead (or other suction maintaining geometry of suction headconfiguration) is suitable for use as part of a medical procedure in isdepicted and described herein with regard to FIG. 8B.

Referring back to FIG. 1 and FIG. 2A, it should be appreciated that thelongitudinal grooves 74 may be covered with portions of the hand. Forinstance, the user may wrap his or her hand around the grip member 22such that the palm of the hand engages the second set 77 of longitudinalgrooves 74 and the user's fingers engage the first set 75 oflongitudinal grooves 74. Moreover, the suction may be varied by using anadjustable sleeve or other mechanism (not shown) that can be coupled tothe grip member 22 and is adapted to cover at least a portion of thelongitudinal grooves 74 of sets 75 and/or 77.

For example, the user adjusts the position of his or her hand as variouslevels of suction are needed. When the aspirator 13 and sleeve 40 aredeep within a patient's body (e.g., wound 800) such that a majority ofthe orifices 62 and the cross-holes are covered by a portion of thepatient's body, air flow into the sleeve 40 is decreased. This may alsooccur if some of the orifices 62 and/or cross-holes become clogged.Without sufficient venting into the sleeve 40, the suction level withinthe interior of the sleeve 40 increases, and tissue may collapse aroundthe aspirator and sleeve combination device. To relieve some of thepressure within the sleeve 40, the user can hold the grip member 22 tocover only a minimal portion of the longitudinal grooves 74 of sets 75and 77, thereby allowing air to flow into the sleeve 40 and relieve someof the pressure on the tissue.

If, on the other hand, the aspirator 13 and sleeve 40 is only partiallyenclosed within the patient's body such that a majority of the orifices62 and the cross-holes are exposed to the atmosphere, air can flowfreely into the sleeve 40 to relieve the pressure within the sleeve 40.As such, the suction level within the interior of the sleeve 40 maydecrease below a threshold level of interest to a user. To increase thesuction within the sleeve 40, the longitudinal grooves 74 of sets 75and/or 77 can be increasingly covered by the user's hand until thedesired level of suction is attained.

Likewise, for example, the aspirator 13 may be used without the sleeve40 to accurately and efficiently drain fluids from a specific area, suchas a surgical site such as shown in FIG. 8B. When placing the suctionhead 18 within a body cavity, the suction head protrusions or ridges 17bridge the adjacent soft tissue and maintain the channels open in thegrooves 21. Thus, if the suction head opening 16 is clogged, fluid, gas,and materials may flow into the channels defined by grooves 21 and intothe orifices 19. The suction head opening 16 also can refer to the boreof the suction head which is in fluid communication with a tubularmember in some embodiments. In one embodiment, the protuberancesdisposed around the opening 16 are sized and arranged to form a flowchannel in the presence of tissue that drapes or otherwise contacts theprotuberances during a medical procedure. In one embodiment, tissue ispinned or isolated away from the suction head and one or more regions ofthe tissue cooperate with opening 16 to form a flow channel.

If the aspirator 13 is placed within a cavity so that is orientedsubstantially orthogonally to a tissue wall, the suction head opening16, as well as the orifices 19 adjacent the end opening, may be elevatedfrom the tissue wall using one or more protrusions extending from thesuction head. In addition, in some circumstances, the fluid, gas, andmaterials may flow into the channels defined by grooves 21 and into theuncovered orifices 19 located father away from the opening 16. In oneembodiment, opening 16 is referred to as a main or primary opening.

FIG. 8B depicts an embodiment of a suction head having a crownedconfiguration with the various protuberances shown disposed in a tissue805 and fluid 810 containing environment such as cavity being accesseddue to a surgical incision. Various arrows are also show in FIG. 8B. Thearrows indicate the direction of fluid flow or the application ofsuction from a remote vacuum source or other device. A viscous film,semi-liquid layer, or a small pool of liquid is depicted by a boldcurved line 805. When using an aspirator in suction head-only mode (nosleeve attached), the suction head and its associate protuberancespushes flexible tissue away from the main opening of the suction head16. A crown or cruciform arrangement of protuberances is suitable forachieving this as other arrangements of protuberances from a suctionhead.

The pushing away of or gap maintaining of tissue draping relative to aprotrusion or ridge extending from the suction head is achieved usingvarious protrusions. In one embodiment, maintaining suction and fluidflow occurs by one or more protrusions 17 interfacing with tissue orother material to avoid a planar or continuously smooth contactingsurface in favor of creating gaps and arcuate flow paths on purpose.FIG. 6B shows an exemplary protrusion 17 relative to end face 83 thatcan displace tissue to maintain a flow channel. The gaps and protrusions17 interfacing with tissue create a frontal area for the fluid to flowrelative to end face 83 and opening 16. Traditional aspirator suctiontips do not have protuberances, and the flexible tissues surround thehole in the suction tip and seal it much like a flapper valve or reedvalve. The tissue is deformed due to the presence of the suction head;however, you can also see that the protuberances keep a path open(frontal area) for fluid flow.

In one embodiment, the length, width, and height of an exemplaryprotuberance range from about 0.001 inches to about 0.20 inches. Theprotuberances disposed on or formed from or otherwise constituting acomponent of the suction head can be any suitable shape and dimensionsuitable for use with a suction head. As examples, protuberances caninclude, without limitation, bumps, knobs, tangs, bosses, non-sharpelements, ridges, spheres, hemispheres, rounded projections and otherobjects and members. In one embodiment, the protuberances are sized andshaped to create a flow channel when in use relative to organs, tissueand other biological materials and structures.

Assembly Fit Profile/Substantially Cylindrical Configuration Embodiments

In one embodiment, the mating surface and associated areas of the handlemember 20 and sleeve 40 may have conical type configurations (e.g.,truncated cone potion with an increasing/decreasing cross-sectional areaalong an axis). Conical configurations, however, often mean that thefriction force joining the handle member 20 and sleeve 40, as anassembly, does not occur until engagement of the sleeve 40 and handlemember 20 is nearly complete. Also, in certain instances, the aspirator13 of the handle member 20 interferes with the end (e.g., distal sleeveend portion 45) of the sleeve 40 before the sleeve 40 is completelyengaged on the handle member 20.

One or more features, such as grooves, ribs, struts, or other structurescan be disposed or formed at the distal end of the sleeve 40 to contactcertain areas of the aspirator 13 of the handle member 20 for engagementpurposes. However, these features may serve to diminish the fluidicperformance of the device and care in their selection and alignment isimportant. In some embodiments, these features at the distal end of thesleeve are avoided because they do not yield a practical benefit, whilesimultaneously complicating the manufacturing of the assembly.

Likewise, these features may introduce tactile ambiguity during theassembly process (e.g., the engagement) of the sleeve 40. For example,the sleeve 40 is made of a material whereby shrinkage during injectionmolding is difficult to predict. Therefore, it is often the case thatthe manufactured sleeve 40 is slightly shorter than initially intended.A short sleeve 40 may ruin any anticipated assembly tactile feedback.Further, for features at the closed end of the sleeve, the distal end,to perform as desired, the sleeve 40 would have to meet the shoulder 37on the handle 20. In addition, features at the distal end of the sleevedisposed within the lumen of the sleeve would have to be contactedsimultaneously; given a sleeve 40 that is slightly shorter thanintended, this may be impossible to implement.

Despite these shortcomings, proper fit engagement between the sleeve 40and handle member 20 is possible using various implementations andconstraints. The sleeve 40 is designed to mate or couple with the handlemember 20 at a substantially cylindrical sleeve coupler 26, 260 and besecured thereby during use of the handle-sleeve combination such thatinterference commences with and continues through sleeve and sleevecoupler engagement. Accordingly, once the sleeve is secured to thehandle, the frictional forces are such that the two components will notdisengage during a medical procedure unless pulled apart by a person ordevice. Additionally, it is preferred that the assembly process (e.g.,the engagement) provide tactile feedback to the user.

For example, when the sleeve 40 and handle member are engaged via asleeve coupler to form a combined secure assembly of both components,the user is able to feel or otherwise sense the gradually increasingfriction associated with the mating or coupling of the components. Thisrelationship is illustrated graphically by FIG. 13, depicting theforce-engagement relationships for two different coupling memberprofiles and thus indicative of a user's tactile experience with such asleeve and aspirator combination process. The two force profiles of FIG.13 also track the engage of the two sleeve coupler designs andassociated sleeves shown on the right (substantially conical) and left(substantially cylindrical) sides of FIGS. 11A-11C.

Given the conditions of a procedure room and the prevalence of fluids,having a comfortable and satisfying process when forming a suctiondevice by combing an aspirator and sleeve is important. The embodimentsdescribed herein relating to a substantially cylindrical sleeve couplerdesign allow a user to complete the combination of both components andhave a level of confidence that a secure fit has been achieved. This isan advantageous design feature. In addition, a high level of strength isnot required for a substantially cylindrical sleeve coupler which isunlike various substantially conical sleeve couplers as illustrated bythe assembly force spikes of FIG. 13.

The designs disclosed herein address many of the assembly shortcomingsrelating to a substantially conical sleeve coupler such as coupler 265shown on the right side of FIGS. 11A-11C in conjunction with sleeve 1205and handle 1255. In contract, as illustrated in FIGS. 9A, 9B, and theleft side of FIG. 11B, preferably the mating areas of the sleeve 1200and sleeve coupler 260 of the aspirator are now substantiallycylindrical. FIGS. 12A and 12B are side cutaway views showing theengagement of an aspirator sleeve 1200 and the interference therewithover an engagement length EL that follows which correspond to the sleeve1200 and sleeve coupler 260 shown on the left side of FIGS. 11A-11C.More particularly, FIGS. 9A and 9B illustrates the substantiallycylindrical profile of the sleeve coupler 260 (e.g., the mating area) ofthe handle member 1250.

FIG. 9A is a perspective view depicting an aspirator 130 that includes asuction head 18, a tubular member 14, a shoulder 37, a barb 24 for asuction source, a handle 1250 and a sleeve coupler 260. FIG. 9B is aperspective view depicting the interface of a tubular member 14 and ahandle member of an aspirator 130 and sleeve coupler 260 and handle1250. The sleeve coupler 260 and handle 1250 are also described withregard to the embodiment shown on the left side of FIGS. 11A-11C andsleeve 1200.

The handle member 1250, as illustrated in FIGS. 9A, 9B, 12A and 12B,includes the sleeve coupler 260 and has a shoulder 37. The handle member1250 additionally includes tube coupling member 260. The aspirator mayinclude additional features, as disclosed above, such as the tubularmember 14 and the suction head 18.

Particular details relating to the engagement of a substantiallycylindrical profile of the sleeve coupler 260 of the handle member 1250relative to an alternative embodiment is illustrated by FIGS. 11A-11Cand FIGS. 12A and 12B. FIGS. 11A-11C includes cutaway views of both asubstantially cylindrical configuration (left) and a substantiallyconical configuration of sleeve couplers or mounts 260, 265. The lefthand portion of each of FIGS. 11A-11C shows features relating to anembodiment that includes a substantially cylindrical sleeve mount orcoupler. The right hand portion of each of FIGS. 11A-11C shows featuresrelating to an embodiment that includes a non-substantially cylindricalsleeve mount or coupler such as a conical sleeve mount or coupler. Inone embodiment, an outer surface of the sleeve coupler 260 portion ofthe handle, which is the portion that contacts the sleeve, has across-sectional profile that is substantially cylindrical along itslength.

The left side of FIG. 11B shows an exemplary sleeve coupler 260 having asubstantially cylindrical profile over an engagement length EL with aninitial engagement point P1 and the end of engagement occurring at pointP2. In FIG. 12A, engagement has started and sleeve 1200 is interferingwith coupler 260 in zone Z1. The engagement length EL has an initialzone or region Z1 and a terminal zone or region Z2. The assembly forceremains substantially the same or gradually increases as the sleeve 1200is engaged to enter zone Z2 and have engagement terminate at point P2.FIG. 11C shows a sleeve 1200 having a volume V on the left side. Thesleeve 1200 is slightly deformed by the substantially cylindricalcoupler 260. FIG. 11C shows a sleeve 1205 having a volume V_(con) on theright side as significantly and asymmetrically deformed by substantiallyconical coupler 265.

The substantially cylindrical shape of the sleeve coupler 260 is chosensuch that the engagement force between the sleeve and the coupler isgradually increasing as the two are paired with interference beingpresent through the engagement length EL in both Z1 and Z2. That said,the assembly force in Z1 and Z2 are not significantly different so thata sudden force spike does not occur in Z2. This follows becauseinterference starts from the time of engagement of the sleeve with thesleeve coupler but the profile of coupler 260 generally conforms to thatof cylinder without significant deviations.

In FIG. 11B, the start of this engagement of a sleeve with substantiallycylindrical coupler 260 starts at point P1 with the sleeve couplerhaving a thickness H1. Interference starts upon engagement at P1. Withthickness H1, the sleeve 1200 and couple 260 interfere. In contrast witha conical coupler 265 interference does not commence with engagement atthickness H₂ which is less than H₁. Instead, with the conical sleevecoupler 265, sleeve 1205 does not interfere with the sleeve coupler 265over the zone Z3 at thickness H2, as shown on right side of FIG. 11B,even though the sleeve 1205 has received the coupler 265. The thicknessH2 of sleeve coupler 265 is not thick enough to engage the sleeve 1205over region Z3. As a result, given the conical taper of sleeve coupler265, any interference and tactile feedback is delayed. When interferencedoes start, at the end of Z3 or after Z3, the conical profile causes theforces to suddenly increase.

A strong assembly force occurs in Z4 as engagement terminates.Engagement can terminate with coupler 265 prior to reaching the shoulderbecause of the high assembly force which must be overcome to push thesleeve 1255 through Z3. As shown, in FIGS. 11A and 11C, the sleeve 1205and coupler 265 are trumpet shaped such that interference does not occurin Z3 and strong assembly forces are required in Z4. In one embodiment,a substantially cylindrical sleeve coupler is a sleeve coupler thatavoids the assembly force profile of a conical or substantially conicalsleeve coupler as described herein. This type of coupler can beidentified in like of the description provided herein and the associatedforce behavior and unwanted force spikes which are avoided while stillproviding tactile feedback over EL.

FIGS. 12A and 12B are side cutaway views showing the engagement of anaspirator sleeve and the interference therewith over an engagementlength EL and generally track the substantially cylindrical assembly ofsleeve 1200 and coupler 260 of FIGS. 11A-11C and the relatednon-quantified assembly force relationship of FIG. 13. As shown, thesleeve 1200 buts against the shoulder 37 of the handle 20 when engaged(e.g., complete engagement). With a substantially cylindrical sleevemount 260 as part of the handle design, the interference of the sleeve1200 and handle member 260 increases the separation force with increasedengagement as the sleeve moves along a member of the handle, from thepoint of first contact to complete assembly. The assembly forcetransitions as sleeve 1200 interferes with sleeve coupler 260 from zoneZ1 to zone Z2 along engagement length EL is a gradual transition and inone non-limiting embodiment can track the curve G1 shown in FIG. 13. Asnoted below, the disclosure is not limited to the relationships of FIG.13, but provides them as informative guidance to distinguishsubstantially cylindrical and substantially conical sleeve couplerprofiles.

To further summarize the benefits of using a substantially cylindricalsleeve coupler some general assembly force versus sleeve-handle engageare illustrated graphically by FIG. 13. Any theory, mechanism ofoperation, proof, or finding stated herein is meant to further enhanceunderstanding of principles of the present disclosure and is notintended to make the present disclosure in any way dependent upon suchtheory, mechanism of operation, illustrative embodiment, proof, orfinding. With being held to any particular theory or mechanism, theforces displayed in FIG. 13 relating to combining an elastic sleeve witheither a substantially cylindrical sleeve coupler G1 and a substantiallyconical sleeve coupler G2 are meant to illustrate general trendsrelating to differences between the respective assembly processes andnot detailed quantitative date.

The graph shows a plot of assembly force versus sleeve-handleengagement, comparing substantially conical G2 and substantiallycylindrical G2 profiles for these two types of sleeve couplers. Asillustrated by FIG. 13, with substantially cylindrical sleeve couplerprofile G1, a significant assembly force exists if there is anyengagement (e.g., high initial slope near the start of engagement). Thisfollows because interference commences with engagement as discussedherein for such a profile G1. By comparison, with substantially conicalsleeve coupler profiles G2, for much of the perceived engagement thereis negligible force (e.g., low initial slope near the start ofengagement). In addition, the force near complete engagement for the G2profile is significantly larger than that at the start of engagement.This follows because the thickness of the conical sleeve couplertypically does not interfere with the sleeve when it first crosses intothe sleeve lumen. In one embodiment, profile G1 is has a force profilethat increases during sleeve engagement and then levels off asengagement is completed. In contrast, profile G2, has a graduallyincreasing force during assembly and then the assembly force increasessignificantly at the end of the assembly process. This results in a userof a substantially conical profile (G2 profile) having excessive forcefeedback at the end of the process. This high force profile at the endof assembly may even result in making assembly impossible. In part, thisdemonstrates the tactile feedback and assembly benefits of thesubstantially cylindrical profile G1.

Internal Geometry of Handle and Internal Fluid Flow Path DesignEmbodiments

In part, the disclosure relates to an aspirator or other medical devicethat includes a flow path through which liquids, gases, debris, andother material can flow through. In particular, a handle or othersupport for a suction device that includes a flow path disposed thereinis one aspect of the disclosure. For some embodiments, a flow path isformed from one or more cavities or volumes that are defined by thegeometry of the inner walls and structures of a given handle or othersupport member. In some embodiments, the handle or support member areformed by a molding process. The handle or support member are formedwith proximal and distal end faces that are in fluid communication witha flow path that is in fluid communication with an aperture or holedefined by each respective end face. These apertures can be used toconnect a tubular member and a barb, respectively, in one embodiment.The flow path allows for fluid, gas or other material transport andspans the inner region of a given handle or support member between theproximal and distal end faces and their respective apertures.

FIG. 10A is a schematic view of a curve 175 a in a plane with alongitudinal axis of rotation in the plane by which a surface or solidof revolution can be generated to define a flow path within a handle orother member. The arrows show a direction of rotation about which thecurve can be rotated relative to the longitudinal axis L_(axis). In someembodiments, the flow path is designed to have a geometric shape thatcan be defined by a surface of revolution. A surface of revolution isone or more surfaces of a solid of revolution. Given that the flow pathis one or more cavities defined by the material of a handle or supportmember, the surfaces that define the cavity of the flow path can besurfaces of revolution. The term revolute can also be used to refer to asurface of revolution or the shape of the fluid flow path within ahandle or other member.

The curve used to generate a given surface or solid of revolution (alsoreferred to as a revolute) can include straight line segments or curvedsegments without limitation. The curve 175 a includes linear and curvedsections. The surface that results from rotating the curve 175 a aboutthe longitudinal axis is shown as fluid flow path 175 b of handle 240 inFIG. 10B. This flow path includes the section of the tubular member 140disposed in the handle as shown in FIG. 10B. In one embodiment, there isan even number of cavities defined from the barb 240 to the suction head180. These are depicted and described in various ways with regard toFIGS. 10A-10D. These cavities can include the suction head bore 110 d,cavity defined by section of tubular member bore disposed in the handle,and a second flow cavity adjacent thereto and a first flow cavity thatincludes the bore of the barb or suction connector. These cavities arein fluid communication with each other and define a flow path. A portionof this flow path is internal to the handle 260. Another portion of thisflow path is external to the handle. The external path includes thesection of the tubular member not disposed in the handle and the suctionhead bore as shown in FIG. 10D. FIGS. 10B and 10C illustrate cutawayviews of the handle member 200 and include details relating to the innerflow path 175 b defined by curve 175 a and the portion of the tubularmember bore disposed in the handle.

In one embodiment, the inner flow path 175 b can also be defined by acombination or sum of three elongate adjacent cavities having differingdimensions. The handle 200 can include a substantially cylindricalsleeve coupler 260 in one embodiment. Alternatively, for other supportmembers for other medical devices that include an inner flow path, asubstantially cylindrical sleeve coupler may or may not be included. Theregions of fluid flow shown relative to the suction head 190 in FIG. 6Asuch as bore 193 are in fluid communication with fluid flow path 175 bin one embodiment.

In FIG. 10B, various subsections of flow path 175 b of the handle member200 are shown. In one embodiment, the flow path 175 b is a cavitydefined by a surface of revolution 175 a. In one embodiment, the flowpath 175 b is a cavity defined by stacked arrangement of elongatecavities. Three cavities (proximal/first fluid flow cavity) 110 a,(transitional or second fluid flow cavity) 110 b, and segment of bore110 c of tubular member in the handle are in fluid communication withone another and each have a respective length L1, L2, L3 and arespective inner thickness T1, T2, and T3. These three cavities 110 a,110 b, and 110 c define a flow path. This flow path continues with thesuction head bore 110 d that has a thickness T4. Elongate cavity 110 ais a truncated cone in one embodiment. The material used to make thehandle 260 is a polymer such as a plastic in one embodiment. The handlecan be formed through various molding processes. In addition, thesuction head 180 can be formed through various molding processes. In oneembodiment, one or both of the suction head and the handle can beprinted using a 3D printer or other similar manufacturing process.

In one embodiment, elongate cavity 110 c is either defined by handle 200or by a tubular member 140 disposed in the handle 200. As shown in FIG.10B, elongate cavity 110 c is the inner bore of tubular member 140. Theouter diameter OD of the tubular member 140 is also depicted herewith.The outer diameter OD is selected to be less than the diameter T4 of thesuction head 190 in one embodiment. Typically, the elongate cavity 110 cis defined by a tubular member 140 having an inner diameter T3 such thatthe tubular member 140 is disposed within the handle 200 a distance L3.In embodiments that do not include a tubular member 140, the length ofcavity 110C is also L3.

In one embodiment, the transition between elongate cavity 110 c andelongate cavity 110 b is a junction between a cavity defined by handleand an inner bore 110 c of member 140. In this way, the handle includesa junction between dissimilar materials in one embodiment. This junctionis formed at the proximal end of the tubular member 140 and the distalend of elongate cavity 110 b. In one embodiment, the thickness T2 ofelongate cavity 110 b is approximately the same distance as the outerdiameter of tubular member 140. In one embodiment, inner diameter ofelongate cavity 110 b is greater than inner diameter of elongate cavity110 c.

In the aggregate, from a cross-sectional view, these three cavitysections 110 a, 110 b, and 110 c form a composite shape. The compositeshape is approximated, from a cross-sectional view, as three rectangularshapes. The inner diameter of the tubular member T3 is less than thethickness T2 in one embodiment. As shown in FIG. 10B, L1 is greater thanor equal to L2. L2 is greater than or equal to L3. L1 is greater thanL3. The thicknesses of each section 110 a, 110 b, and 110 c are alsoincreasing when moving from the tubular member 140 to elongate member240—that is moving distally to proximally. In one embodiment, elongatehollow member 240 is suction port or barb. As shown, T1 is greater thanor equal to T2 which in turn is greater than or equal to T3. In oneembodiment, the handle 260 as shown in FIG. 10B includes a metal tubularmember such as tubular member 140. The tubular member has a bore, whichacts as a flow cavity or flow path.

Inside the handle, this is a fluid flow path. The flow path can extendthrough the tubular member bore to the bore of the suction head in oneembodiment. In addition, the handle portion which surrounds the tubularmember effectively defines a tubular cavity 289 that surrounds andsecures the tubular member 140. The proximal end (right side) has thebarb 240 and a proximal cavity or fluid flow cavity 110 a. The tubularcavity 289 is not typically a flow cavity, with the flow of fluid beingcarried through the tubular member 140 disposed in the tubular cavity ofthe handle 260. [0208] In one embodiment, the stepped or stackedarrangement of adjacent and continuous cavities 110 a, 110 b, and 110 cis referred to as a spyglass configuration or spyglass shaped cavity.

In one embodiment, the elongate cavities form or define an internalfluid flow path. The longitudinal axis of the handle, which is disposedalong the internal flow path, is the axis about which a stepped curve orline is rotated to define a volume within the handle. This volume is anexemplary internal flow path in one embodiment. The geometry of theinternal flow path is a stepped revolute in one embodiment. Thesecylindrical segments effectively have a spyglass or telescoping ornested arrangement such that each subsequent segment can nest or fitwithin the preceding segment even though the shapes define cavities,which are fixed in the handle and bounded by the inner surface geometryof the handle 200. In one embodiment, the handle defines a region of twoor more elongate cavities arranged along a central longitudinal axis orshifted relative thereto.

In one embodiment, the stepped features of the flow path 175 b of ahandle 200 become successively smaller, from proximal end to distal end,until the last sections of the flow path meets the tube 140 which has acylindrical diameter and bore 193 of suction head (if a suction head ispart of the design). Each cavity section 110 a, 110 b, and 110 c canhave various cross-sections and need not be cylindrical. The steppedrevolute features of the flow path 175 b may include draft (taper). Flowpath section 110 a includes a positive draft angle, and section 110 bcan optionally include a positive draft angle. At the junction between110 a and 110 b, a sharp corner or turn or stepped transition 233 ispresent.

This in contrast to corner 122 a in which a radius or curve is presentand a sharp edge is avoided. T2 is generally a smaller distance than T1.From the barb end 240, typically there will two or more cavities. In oneembodiment, only three cavities are used to define the flow path. Also,the diameter of the mouth at the barb 240 is T1 in some embodiments. Thethickness of T1 and the wall of barb 240 is configured to providesufficient wall thickness to allow coupling to a suction source via aconduit or tube that attaches to barb 240.

FIG. 10D shows the suction head 180 which is in fluid communication withthe bore 110 c of the tubular member 140. Additional details relating tothe suction head 180 and the elongate cavity sections of handleincluding the interface of the suction head bore 110 d, flared tube end122, and suction head housing is shown. Elongate cavity 110 c, which isthe inside of the tubular member 140, is defined by the inner surface ofthe tubular member 140. The inner surface of the suction head 179defines the suction head bore 110 d. The suction head bore 110 d is acavity that is in fluid communication with elongate cavity 110 c of thetubular member, which the bore of the tubular member. The thickness ofthe suction head bore is shown as T4 in FIG. 10D. These two cavities,179 and 110 c come together at a flared region 122 of the tubular memberthat has a flaring angle.

As shown in FIG. 10D, the flared region has a corner 122 a or surfacejunction 122 a that is where inner suction head surface 179 terminatesat the flared end of the tubular member which is disposed in the body ofthe suction head 180. This corner 122 a is a transitional region and isengineered to be a smooth curve in one embodiment. With respect to FIG.10B, in one embodiment, cavity 110 d is a cylinder or a cylinder with ataper. The taper can be greater than or equal to about 0.5 degrees inone embodiment. The diameter of cavity 110 d is greater than the cavity110 c in one embodiment. Elongate cavity 110 a and elongate cavity 110 bhave a cavity interface or junction 245. This interface 245 is atransition from thickness T1 to thickness T2. Elongate cavity 110 c andelongate cavity 110 c have a cavity interface or junction 247. Thisinterface 247 is a transition from thickness T2 to thickness T4 and T3.Thickness T3, the inner tube diameter, is typically less than thicknessT2.

In one embodiment, the corner 122 a has a curve such a circular sectionor sector having a radius, an elliptical section having an ellipticalcurve, or another curve. The corner 122 a near the flared region 122 isconstrained to avoid a sharp edge or abrupt transition or step.

Engineered Clearance of Aspirator Sleeve Combination

After a sleeve is assembled with the aspirator, the proximal end of theelastic sleeve conforms to the profile of the handle and isapproximately aligned with the handle over a distance from the shoulderuntil a bend is encountered along the tubular member. In one embodiment,as part of the design of the combined sleeve and aspirator, one moreclearances have been engineered into the distal end or tip of thesleeve. The one or more clearances in this sleeve area allow the sleeveto have a more gradual bend because of the skew angle between an axis ofthe bent sleeve tip and an axis of the bent distal portion of thetubular member. By constraining this skewing angle and optionally otherskewing angles and clearances, the angle by which the sleeve bendsrelative to the longitudinal axis of the handle is reduced such that thesleeve appears straighter even though it contains a tubular member witha bend. In one embodiment, this gradual bend of the sleeve allows thecombination of sleeve and aspirator to more closely follow the shape ofa straight, traditional, Poole suction device.

Various embodiments of the aspirators described herein benefit fromincluding an engineered clearance between the suction head and the innersleeve wall. For example, this clearance is typically a gap between theend face of the suction head and the terminal end of the inner sleevewall near the end of the elastic sleeve. This clearance SC is shown inFIGS. 14A, 14B, and 15A, 15C and 15D. Although SC can also include anyclearance distance between the suction head and the sleeve wall at thedistal end of the sleeve when the suction head is disposed therein afteraspirator sleeve assembly, as shown in FIG. 14A, preferably, SC is thedistance between the inner sleeve wall end portion and an end face orend region of the suction head or a side clearance relative to the sideof the suction head as shown in FIGS. 14B and 15A, 15C and 15D. Theclearance between the suction head to the inner sleeve wall SC isadvantageous relative to aspirators that lack such a clearance.

In various embodiments, as shown for example in FIGS. 14A, 14B, and15A-15D and other embodiments described and depicted herein, including aclearance between the suction head and the inner sleeve wall permits thevarious skewing angles described herein. In contrast, for an aspiratorand sleeve system that lacks such a clearance and the associatedpossible ranges of skewing angles, there is interference between thesuction head and the end portion of the sleeve. This creates problemssuch as sticking and unwanted sleeve bending or extreme hooking when thesleeve and aspirator are combined to form an assembly.

In one embodiment, one or more engineered clearances at the tip area ofsleeve allows the axis of the tubular member of the aspirator after abend in the tubular member to be askew with the axis of the sleeve inthat area. FIGS. 15A, 15C and 15D show various embodiments of sleeve andaspirator combinations 500. The region R1 shows a tubular member and asleeve aligned before the bend B. The region R2, after region R1,includes the bending sleeve and the bend B of the tubular member. Insome embodiments, the sleeve bending occurs before or after the tubularmember bend B. Although discussed in more detail herein, this can beseen with the axis passing through the bent tubular member shown by linesegment JK as compared to the axis through line segment LN thatcorresponds to an axis of the bent sheath 40.

An exemplary engineered clearance SC associated with the suction head 18and its respective engagement with sleeve 40 as well as variousclearances D_(fy) between the bent tubular member 14 and the innersleeve wall 143 are shown in FIGS. 14A and 14B. The engineered clearanceSC near the suction head clearance improves suction and fluid transferthrough the sleeve and into tubular member 14 and results in lessfriction between the suction head 18 and the sleeve 40 during sleeve andaspirator coupling. In one embodiment, the engineered clearancesdescribed herein are greater than about zero to about 0.2 inches.

In one embodiment, there is an engineered clearance SC, which is adistance, from a point on suction head, such as a point on distal endface of suction head, to the distal terminus of the inner wall of thesleeve. This clearance within the sleeve near its distal tip as measuredfrom a normal from the distal end face of the suction head can rangefrom about 0.080 to about 0.11 inches. In one embodiment, the clearanceranges from about 0.005 inches to about 0.100 inches, wherein theclearance is between the distal end face of the suction head and thesleeve inner surface. In one embodiment, the clearance between innersleeve wall and a point of suction head or tubular member ranges fromabout 0.005 inches to about 0.100 inches.

In one embodiment, there is radial engineered clearance SC extendingfrom a normal to the surface of the tubular member to the inner sleevewall of the sleeve. This radial clearance can range from about 0.001inches to about 0.020 inches. The various engineered clearances SC canvary relative to the tubular member, the suction head, and otherwisewithin the sheath as space or clearance is set which permits orconstrains various skewing angles, alone or in combination as designparameters.

In addition to the generalized clearance SC which include radial oraxial clearances as described herein without limitation, otherclearances or spaces can be described relative to the aspirator andsleeve designs. As a result of these two axes being shifted relative toeach, there are various clearances such as clearances D_(fy) that arepresent by design. These clearances are shown in a y directionalrelative to a range or distance D_(fx). The distance D_(fx) is an offsetrelative to the longitudinal axis of the sleeve 40. D_(fx) provides onereference frame to measure the various D_(fy) clearance or deflectionvalues, which vary along the D_(fx) range.

In one embodiment, a relative extremum such as the maximum D_(fy) valueof the set of D_(fy) values that range of distance D_(fx) can beidentified as the maximum engineered clearance value. This is but oneexemplary measurement of clearances. As discussed below, the variousangles that constrain the relationship of the tubular member, suctionhead and inner sleeve wall 143 are selected by design to createclearances between these various components. The angle LMJ is oneskewing angle that can be constrained to allow one or more clearancessuch as the D_(fy) clearances shown. Other skewing angles can also beconstrained as described herein. Example skewing angles, as can be seenwith regard to FIGS. 15A and 15B, include without limitation one or moreof the following angles: angle ABL, angle ABJ, angle LMJ, angle ABJ,angle ACL, angle ACJ and other combinations of angles shown in FIGS. 15Aand 15B.

Angle ACJ corresponds to the bend angle of distal portion (upperportion) of tubular member relative to the handle and is one skewingangle that can be used to constrain one or more clearances. Angle LMJcorresponds to the skewing between the upper portion of the sleeve andthe upper portion of the tubular member after the bend is anotherskewing angle that can be used to constrain one or more clearances.Angle ACL corresponds to the bend angle of sleeve relative to the handleand is one skewing angle that can be used to constrain one or moreclearances. In one embodiment, the angles, ACL and ACJ range from about10 degrees to about 45 degrees.

The engineered clearance between the tubular member and the sleeveD_(fy) results in a sleeve that is less sharply bent as would be thecase if D_(fy) were removed. With D_(fy) removed, the sleeve and thetubular member 14 would closely track and conform to each other and thesleeve would appear considerably more bent and hooked. Such bending andhooking make the combination sleeve and aspirator combination harder toassemble and also make the combination look less like other suctiondevices with a straighten sleeve end portion such as a Poole suctiondevice.

As a result, the clearances engineered between an elastic sleeve and atubular member, when both are combined together, address these problems.As discussed herein, the various clearances between the sleeve andelements disposed within the sleeve constrain skewing angles between thevarious axes described herein constrain and establish ranges for theseangles. Additional details relating to the engineered clearance isdiscussed herein with regard to FIGS. 14A-16.

In one embodiment, the arrangement of two combinable components of asuction system are sized and arranged relative to other components toprovide an amount of clearance. In one embodiment, clearance refers to adistance between two objects or an amount of clear space. A givenclearance SC can be described in terms of a distance in one or moredirections relative to the objects at issue such as a suction headsurface, inner sleeve wall surface, tubular member surface and otherdistances measured relative to sleeve inner wall and a surface point ofthe tubular member or suction head in distal region of sleeve. ClearanceSC can also be described in terms of one or more volume elements inwhich object pairs do not collide or only selectively collide at certainpoints, lines angles or surfaces. In one embodiment, various angularranges of intersecting or offset axes are described herein which provideconstraints for the axial and angular positions of a sleeve relative tothe tubular member of an aspirator. These angular and axial constraintsor parameters are suitable for achieving various engineering clearancesof interest.

As illustrated in FIGS. 14A, 14B, 15A, 15B, and 16, the suction head 18and tubular member 14 may include one or more predetermined clearancessuch as a threshold clearance. The foregoing clearances can beengineered to address various design and user interactions with asuction device such as assembly a sleeve with an aspirator. A clearanceis interposed between a sleeve and the suction head and or the tubularmember to which it is attached in one embodiment. This clearancefunctions to more easily allow aspirator 13, 130 to combine with asleeve 40, 120 and provides one or more offset distances between thetubular member, the suction head and the inner wall of the sleeve invarious embodiments. The various axis such as the longitudinal axis ofeach of the tubular member and sleeve, for the respective bent andunbent portions as well as the longitudinal axis of the handle and anyoffset axis relating to the foregoing can be described as a first,second, third, . . . . Nth axis without limitation.

More particularly, FIGS. 14A and 14B illustrate exemplary clearanceassociated with the suction head 18 and its respective engagement withsleeve 40. The inner surface 143 of the sleeve 40 is shown. A bend angle145 can be measured relative to a tangent to inner surface 143. Thesleeve can be positioned relative to a suction head with a clearance Dbetween them. The sleeve 40 can be positioned relative to a suction headwith a clearance D between them. In one embodiment, D ranges from about0.005 inches to about 0.050 inches.

FIG. 15A illustrates a cutaway view of engineering clearance SC relativeto the suction head 18 attached to a tubular member 14 having a bendingdisposed within the sleeve 40. D_(fy) can range along various valuesalong the bent section of the sleeve. In one embodiment, an average ofthese values can be used to measure the engineered clearance. In otherembodiments, the maximum D_(fy) value from tubular surface to innersleeve wall is used as the engineered clearance.

FIG. 15B is a schematic representation that depicts some of the variousaxial and angular relationships of FIG. 15A without the aspirator andsleeve to allow the various angles, axis, and distances to be moreeasily viewed. FIGS. 15C and 15D show additional embodiments 520, 530 ofaspirator and sleeve combinations that include clearances SC that varyrelative to the SC of combination 500 in FIG. 15A. The angles, linesegments and coordinate system of FIG. 15A are also used to depictsimilarly oriented segments and angles for aspirator assemblies 520, 530in FIGS. 15C and 15D even though the distances and angles in embodiments520, 530 differ based on changes to one or more design parameters suchas differing SC values. The assembly of these elements, sleeve andtubular member, 500, 520, 520 relative to the distal end of the sleevecan be described in terms of various axial, angular and other metrics todescribe certain features relating to engineered clearances within thesleeve 40.

In one embodiment, the skewing angles for FIG. 15A vary based on one ormore parameters for combination device 500 including an engineeredclearance SC. For example, in one embodiment angle ABJ ranges from about24° to about 32°. In one embodiment angle ABJ is 28°±4°. For example, inone embodiment angle LMJ ranges from about 5° to about 15°. In oneembodiment angle LMJ is 10°±5°.

In one embodiment, the skewing angles for FIG. 15C vary based on one ormore parameters for combination device 520 including an engineeredclearance SC. For example, in one embodiment angle ABJ ranges from about33.5° to about 41.5°. In one embodiment angle ABJ is 37.5°±4°. Forexample, in one embodiment angle LMJ ranges from about 2° to about 6°.In one embodiment angle LMJ is 4°±2°.

In one embodiment, the skewing angles for FIG. 15D vary based on one ormore parameters for combination device 530 including an engineeredclearance SC. For example, in one embodiment angle ABJ ranges from about32° to about 40°. In one embodiment angle ABJ is 36°±4°. For example, inone embodiment angle LMJ ranges from about 5° to about 15°. In oneembodiment angle LMJ is 10°±5°.

In one embodiment, one or more clearances, such as a radial and/or anaxial clearance between inner sleeve wall and suction head, is desirablebecause it constrains the shape of triangle BMC as shown in FIGS. 15A,15C, and 15D. The various clearances selected constraining the skewingangles which in turn shift and flatten triangle BMC such the sleeve isnot tightly coupled against the tubular member or otherwise interferingwith it during and/or after assembly. A tight fit between sleeve andtubular member causes sharp bending and makes assembly the sleeverelative to the tubular member, suction head and handle difficult or notpossible in some cases.

Prior to discussing some of the clearance features of the disclosure itis informative to consider some geometric axial and angulartransformations that can occur as a result of using a tubular memberwith one or more bends. The various sets of axis and angles can beunderstood by considering an aspirator with a straight tubular memberand a straight sleeve. In such an example, the longitudinal axis of thetubular member and the sleeve would be substantially aligned such thatthere was a common longitudinal axis for the tubular member, the handleof the aspirator and the sleeve.

Now, if the straight sleeve and the straight tubular member weresimultaneously bent, the longitudinal axis shared by both sleeve andtubular member would shift and deviate from the first shared axis. Inturn, the bent portion of the sleeve and the bent portion of the tubularmember would each have their own relative axis through their respectiveportions. Skewing of various axis because of tubular member bending andsleeve bending result in different axes and angles which constrain thearrangement of device components.

Constraining the arrangement and position of device components viavarious angles and certain clearance distances SC allows for a range ofproduct designs that use a sleeve and an aspirator that are easier toassemble and that can, in some embodiments, have a more gradual sleevebend in assembled form as a result of the clearance selected. This moregradual sleeve bend allows the assemble device to resemble a Poolesuction device in one embodiment. These angles are relevant whendesigning the clearances associated with the interplay of sheath,suction head and tubular member when the aspirator and sheath arecombined. As a result, the engineered clearances possible can beconstrained by these various angles, generally referred to as skewingangles.

As shown in FIGS. 15A, 15B 15C, and 15D, the aspirator has alongitudinal axis L_(axis) (unbent) that is disposed within the tubularmember 14 and the handle (not shown). On the various line segments,alternatively described as axes, points A, B, C, D, L, M, N, J and K areshown which define various line segments as end points and also can beused to identify various angles. These coordinates can be used to depictclearance SC and the skewing angles in exemplary embodiments 500, 520and 530 which correspond to different exemplary product designs havingdiffering SC values or other differing angles or proportions. Threepoints of intersection B, C, and M for segments or axis are shown. Thebend of the tubular member 14 that contacts or is otherwise closest tothe inner wall of the sleeve 40 occurs at point B. The line segment ADand component line segments AB and BD thereof are disposed along thelongitudinal axis L_(axis). Line segment or axis LN includes linesegments LM, MC, and CN as component line segments. Line segment or axisJK includes line segments JM, MB, and BK as component line segments.

The portion of the aspirator (disposed on the distal side of the figure)that includes the suction head 18 and the section the tubular memberthat continues after the bend B has its own relative longitudinal axisdisposed along segment JB. The bending of the tubular member 14effectively transforms the unbent longitudinal axis of segment AD(L_(axis)) to a bent longitudinal axis JK. Similarly, the bending of thesleeve 40 from a straight longitudinal axis that tracks axis AD to abent longitudinal axis LCN results in a skewing of the bent distalsleeve portion and the bent distal tubular member portion.

As a result, angles LMJ, ABL, ABJ, and ACL can vary over differentranges and are constrained based on the engineered clearance value for aparticular aspirator and sleeve assembly design. Thus, one or moreskewing angles are a function or otherwise permitted based on theengineered clearance SC for a given embodiment such as 500, 520, 530 andothers as suited for particular aspirator and sleeve dimensions andrelative clearances associated with such dimensions and sleeveproperties. This angle and the other angles are permitted or constrainedby the SC value in one embodiment. Thus, in one embodiment, anengineered clearance between inner wall of sleeve and the suction head,such as the side of suction head or from the distal end face of thesuction, facilitates the assembly process, and reduces the sleeveskewing or bending from the tubular member. In this way, the skewingangles vary as a function of or are constrained by the engineeredclearances. This features works in conjunction with substantiallycylindrical sleeve mount to ease assembly.

FIG. 16 illustrates a partially cutaway view of engineering clearanceassociated with the suction head 18 and its respective engagement withsleeve 40, including bending of tubular member 14, in a fully engagedconfiguration. For example, the substantially cylindrical profile of thesleeve coupling area 26 (e.g., the mating area) of the handle member 20is mated with the sleeve 40.

Providing a clearance allows for utilization of familiar product shapesand forms, reminiscent of classic suction instrument designs. Forexample, the handle member 20 may be reminiscent to the classicAndrews-Pynchon design. When the sleeve 40 is assembled, the elasticsleeve conforms to the curvilinear profile of the handle member 20(e.g., the bending of tubular member 14). In one embodiment, a clearancehas been engineered, into the distal area (e.g., the distal sleeve endportion 45 of the sleeve 40) to allow the sleeve 40 to have a gradualbend. The gradual nature of the bend and the degree of bending resultsin a combination of sleeve 40 and handle member 20 that visually andtactilely more closely approximate those of straight, traditional,Poole-type suction handle. This gradual bend is obtained by setting oneor more skewing angles such that one or more skewing angle ranges fromgreater than about 1 degree to about 3 degrees. In one embodiment, theskewing angle is greater than about 2 degrees and less than about 10degrees. In another embodiment, the angle between the longitudinal axisand the sleeve longitudinal axis, ranges from greater than about 20degrees to less than about 45 degrees.

In an example embodiment, gradual bending of the assembly may furtherinclude bearing flats near the suction head 18 of the sleeve 40. Asshown in FIG. 7A, optionally bearing flats, a molded rib or otherstructure that is part of the sleeve or another component that isadhered to or otherwise incorporated as part of the sleeve canoptionally be disposed in region 80. In one embodiment, bearing flats ofthe sleeve 40 are designed to interface with the plurality of lobes orprotuberances of a suction head. Accordingly, the bearing flats aretypically disposed closer to the distal sleeve end portion 45 of thesleeve 40. In various embodiments, these flats are not used.

The protrusions of the suction head form an exemplary cruciformcross-section (e.g., the cross-section defined by suction headprojections 17 of the suction head 18 and aid the process of sleeveassembly in some implementations. In one embodiment, the assembledsuction set/combination device is configured to have a gradual bend withribs or other elongate guides disposed within the sleeve and near theopening of the sleeve at its base. These ribs or guides or other bearingflats are designed to interface with the cruciform cross-section of thesuction head. In addition, the flats can help simplify the process ofsleeve assembly where the sleeve is elastically deformed to accommodatea bent cannula and the curvilinear profile of the suction handle.

In one embodiment, the bearing flats provide a degree of structuralsupport or reinforcement along certain regions of the sleeve. As aresult, the bearing flats provide additional support and tactilefeedback to a user combining the device when the sleeve 40 iselastically deforming to accommodate the curvilinear profile of thesuction handle. In one embodiment, four bearing flats are utilized, onefor each protrusion or lobe of the cruciform cross-section of thesuction head. In one embodiment, a bearing flat is paired with each lobeor protrusion of the suction head. In one embodiment, the bearing flatsare sized and arranged to align with a plurality of lobes of suctionhead having a cruciform cross-section. The number of lobes and bearingflats are typically less than about six.

By providing a set of components, such as an aspirator and a sleeve, aclearance at the suction head area is deliberately formed to accommodatedegrees of skewing or deflection relative to one or more axes.Specifically, the clearance accommodates skewing or deflection of theaxis of the suction head 18 and tubular member 14 relative to the axisof the sleeve 40 in that area. This skewing differential between thetubular member 14 and the sleeve 40 is illustrated by FIGS. 15A. 15C and15D.

To provide an alternate reference frame relative to the line segmentsand coordinates of FIGS. 15A-15, two directional parameters D_(fx) andD_(fy) are shown with regard to the bent sleeve and handle assembly andprovide exemplary ranges or distances over which a clearance can beformed relative to the inner sleeve wall and a normal measure relativeto a surface of a suction head or the tubular member. In one embodiment,D_(fx) and D_(fy) result from the clearances SC chosen near the suctionhead, which limit how close it can come to the inner wall of the sleeve.

In one embodiment, the installation of a sleeve relative to a suctiondevice can be configured such that a tight fit between the terminus ofthe tubular member (e.g., suction head 18) and sleeve (e.g., sleeve 40)in the suction head area of the assembly. This tighter fit may force theaxis of the suction head and tube to be coincident with that of thesleeve in the suction head area. Functionally, this leads to anoticeably bent suction device when assembled for Poole-type suction.The tight fit of the sleeve and suction head additionally leads toundesirable resistance during assembly of the sleeve (e.g., mating ofthe sleeve).

Combination of Assembled Handle and Drainage Channels

The device discussed above improves the functionality of the handlemember 20 when the sleeve 40 is combined with the handle to form aPoole-type suction device. Poole-type suction involves a process ofaspirating a volume of irrigation and body fluids from an open-surgerywound (e.g., wound 800) as shown with regard to FIG. 8A. A Poole-typesuction device creates a drainage and suction path, to a point ofsuction, via channels formed by interleaved shells. TraditionalPoole-type suction devices have a small handle area that primarilyfunctions to provide hardware to couple an outer rigid sleeve. Thisrigid sleeve creates the drainage/suction path. Therefore, the suctionset may be referred to as a Poole-type suction device when the sleeve 40is assembled to the handle member 20. Effectively, one feature of thedisclosure relates a method of converting a handle-based suction devicesuch as member 20 to a Poole-type suction device. In general, themethods described herein provide tactile feedback to a user with regardto a provided sleeve and aspirator and also ease assembly thereof.

Some designs may not utilize the entire handle as is the case for atypical Poole-type suction device. For example, designs may completelyventilate one side of the handle into the internal cavity formed by thesleeve and the suction handle. However, the top side of the suctionhandle does not provide this functionality entirely. For example,regions on the top of the handle are a typical place at whichventilation is blocked.

By comparison, the device disclosed herein provides channeling on boththe top and bottom sides of the handle member 20. This integration,between the handle member 20 and the sleeve 40 effectively makes theentire assembly a Poole-type suction device. Moreover, this assembly isnot sensitive to orientation in the wound (e.g., top side suction vs.bottom side suction). With the straighter profile of the sleeve 40,there may be a tendency for the operator to disregard orientation of thePoole-type suction handle member 20 during use. By implementing completedouble-sided venting, Poole-type suction performance is improvedregardless of orientation and user actions.

In one embodiment, the aspirator is of a singular construction orintegral such that its components or subassemblies are all a commonmaterial such as a molded polymer or metal. An all polymer or all metalaspirators are examples of such constructions and can be described asunitary in some embodiments. In some embodiment, two or more of thecomponents of a suction catheter can be different materials ormanufactured using different processes and at different points in time.In some embodiments, an aspirator or suction catheter includes two ormore of, for example, a suction head, a tubular member/cannula, anelastic sleeve and a handle member.

More generally, as used herein, the term unitary construction or unitaryencompasses embodiments that are of a singular construction as well asembodiments in two parts of combined to form an assembly or combination.Thus, if a metal tube is coupled to a plastic handle and plastic suctionhead in some manner to form a device such as device can be referred toas unitary suction catheter. As noted above, in other embodiments, theterm “unitary” can also refer to an object that is a single piece. Forexample, an object formed from a single injection molding, e.g., withoutassembly or addition of further parts can be described as unitary orhaving a unitary structure.

In the description, the invention is discussed in the context ofsurgical aspirators and sleeves; however, these embodiments are notintended to be limiting and those skilled in the art will appreciatethat the invention can also be used for any applications where fluidremoval and/or partial vacuum applications are required.

Although the preceding and following text sets forth a detaileddescription of different embodiments of the invention, it should beunderstood that the legal scope of the invention is defined by the wordsof the claims set forth at the end of this patent. The detaileddescription is to be construed as exemplary only and does not describeevery possible embodiment of the invention since describing everypossible embodiment would be impractical, if not impossible. Numerousalternative embodiments could be implemented, using either currenttechnology or technology developed after the filing date of this patent,which would still fall within the scope of the claims defining theinvention.

The aspects, embodiments, features, and examples of the invention are tobe considered illustrative in all respects and are not intended to limitthe invention, the scope of which is defined only by the claims. Otherembodiments, modifications, and usages will be apparent to those skilledin the art without departing from the spirit and scope of the claimedinvention.

The use of headings and sections in the application is not meant tolimit the invention; each section can apply to any aspect, embodiment,or feature of the invention.

Throughout the application, where compositions are described as having,including, or comprising specific components, or where processes aredescribed as having, including or comprising specific process steps, itis contemplated that compositions of the present teachings also consistessentially of, or consist of, the recited components, and that theprocesses of the present teachings also consist essentially of, orconsist of, the recited process steps.

In the application, where an element or component is said to be includedin and/or selected from a list of recited elements or components, itshould be understood that the element or component can be any one of therecited elements or components and can be selected from a groupconsisting of two or more of the recited elements or components.Further, it should be understood that elements and/or features of acomposition, an apparatus, or a method described herein can be combinedin a variety of ways without departing from the spirit and scope of thepresent teachings, whether explicit or implicit herein.

The use of the terms “include,” “includes,” “including,” “have,” “has,”or “having” should be generally understood as open-ended andnon-limiting unless specifically stated otherwise.

The use of the singular herein includes the plural (and vice versa)unless specifically stated otherwise. Moreover, the singular forms “a,”“an,” and “the” include plural forms unless the context clearly dictatesotherwise. In addition, where the use of the terms “about” or“approximately” are before a quantitative value, the present teachingsalso include the specific quantitative value itself, unless specificallystated otherwise. As used herein, the term “about” refers to a ±10%variation from the nominal value. As used herein, the term“approximately” refers to a ±10% variation from the nominal value.

It should be understood that the order of steps or order for performingcertain actions is immaterial so long as the present teachings remainoperable. Moreover, two or more steps or actions may be conductedsimultaneously.

Where a range or list of values is provided, each intervening valuebetween the upper and lower limits of that range or list of values isindividually contemplated and is encompassed within the invention as ifeach value were specifically enumerated herein. In addition, smallerranges between and including the upper and lower limits of a given rangeare contemplated and encompassed within the invention. The listing ofexemplary values or ranges is not a disclaimer of other values or rangesbetween and including the upper and lower limits of a given range.

What is claimed is:
 1. An aspirator comprising: an elongate handledefining a fluid flow cavity, the elongate handle comprising a proximalend face, a suction connector extending from the proximal end face, asubstantially cylindrical sleeve mount comprising an outer surface, anda shoulder, wherein the substantially cylindrical sleeve mount is inrelief with respect to the shoulder and extends distally therefrom,wherein the substantially cylindrical sleeve mount defines an aperture,wherein the suction connector defines a suction connector bore, thesuction connector bore in fluid communication with the aperture and thefluid flow cavity.
 2. The aspirator of claim 1 further comprising: atubular member extending from the aperture, wherein the tubular membercomprises a proximal tube end and a distal tube end, wherein theproximal tube end is disposed in and secured by the handle, the tubularmember defining a tubular member bore, wherein the distal tube end isflared.
 3. The aspirator of claim 1 further comprising: an elasticsleeve, the elastic sleeve defining a plurality of vent holes, a sleevelumen and a sleeve inner wall, the elastic sleeve comprising a sleevetip and a sleeve rim, wherein the sleeve rim defines a sleeve opening.4. The aspirator of claim 3 wherein substantially cylindrical sleevemount comprises a mount thickness and a mount length, wherein the mountthickness and mount length are sized such that during sleeveinstallation on the sleeve mount the sleeve inner wall interferes withthe outer surface of the sleeve mount upon the substantially cylindricalsleeve mount entering the sleeve lumen.
 5. The aspirator of claim 4wherein interference between sleeve inner wall and the outer surfacecontinues along the mount length during the installation, wherein theinstallation is complete when the sleeve rim contacts the shoulder. 6.The aspirator of claim 2 further comprising: an elastic sleeve, theelastic sleeve defining a plurality of vent holes, a sleeve lumen and asleeve inner wall, the elastic sleeve comprising a sleeve tip and asleeve rim, wherein the sleeve rim defines a sleeve opening, wherein thesleeve lumen is sized to receive the tubular member and to interferewith the outer surface of the sleeve mount upon the sleeve mountentering the sleeve lumen.
 7. The aspirator of claim 6 whereininterference between sleeve inner wall and the outer surface continuesalong an engagement length during installation, wherein the installationis complete when the sleeve rim contacts at the shoulder.
 8. Theaspirator of claim 1 wherein the substantially cylindrical sleeve mounthas a longitudinal axis, wherein an angle of taper of the outer surfaceof the substantially cylindrical sleeve mount measured relative to thelongitudinal axis is less than about 2 degrees.
 9. The aspirator ofclaim 3 wherein a sleeve engagement zone is defined by a region ofoverlap between outer surface and sleeve inner wall wherein interferencebetween the elastic sleeve and substantially cylindrical sleeve mountoccurs in the sleeve engagement zone.
 10. The aspirator of claim 2further comprising: a suction head comprising a body, a distal suctionhead end face and a proximal suction head end face, the suction headattached to the distal tube end; the body defining a primary opening anda suction head bore, the distal suction head end face surrounding theprimary opening, the proximal suction head end face defining an outputaperture, the output aperture in fluid communication with the suctionhead bore and the primary opening; and a plurality of protuberancesdisposed radially around the primary opening, each protuberancecomprising a first region and a second region, the first regioncantilevered relative to the distal end face and extending distallyrelative to the primary opening, the second region extending from bodyto define a ridge.
 11. The aspirator of claim 2 further comprising: asuction head defining an opening and a suction head bore, the opening influid communication with the suction head bore, the suction headattached to the distal tube end, the suction head comprising a pluralityof protuberances symmetrically arranged around the opening, each of theprotuberances being an extension of a surface of the suction head in oneor more directions.
 12. The aspirator of claim 2 wherein the fluid flowcavity is further defined by the suction connector bore; an elongatesection of the tubular member bore disposed in the handle and in fluidcommunication with the suction connector bore; and a transitional cavitydisposed between the suction connector bore and the elongate section ofthe tubular member bore, the transitional cavity disposed within thehandle.
 13. The aspirator of claim 12 wherein a diameter of thetransitional cavity is less than a diameter of the suction connectorbore at interface of transitional cavity and suction connector bore. 14.The aspirator of claim 3 further comprising: a tubular member extendingfrom the aperture, wherein the tubular member comprises a proximal tubeend and a distal tube end, and a suction head attached to a distal tubeend, wherein an engineered clearance distance is defined between asurface of the suction head and an inner surface of the sleeve such thata skewing angle is constrained when elastic sleeve is installed onhandle, wherein the tubular member comprises a bend.
 15. The aspiratorof claim 14 wherein the skewing angle is defined by longitudinal axis ofthe tubular member proximal to the bend and longitudinal axis of sleevedistal to the bend.
 16. The aspirator of claim 2 further comprising atubular member defining a bend, the tubular member comprising a proximaltube end and a distal tube end, the proximal tube end disposed in thehandle, the tubular member extending from substantially cylindricalsleeve mount, wherein a section of the tubular member distal to the benddefines a tubular longitudinal axis, wherein the substantiallycylindrical sleeve mount is sized to receive an elastic sleeve such thatthe bend is disposed within the sleeve.
 17. The aspirator of claim 14wherein a section of the elastic sleeve distal to the bend defines asleeve longitudinal axis, wherein a clearance is defined between asleeve inner surface of the elastic sleeve and an outer surface of thetubular member by a skewing angle between the longitudinal axis and thesleeve longitudinal axis.
 18. The aspirator of claim 5 wherein theinterference is a nominal interference of the sleeve inner wall to amating diameter of the outer surface of the sleeve mount, wherein thenominal interference ranges from about 0.010 inches to about 0.020inches.
 19. The aspirator of claim 7 wherein the engagement lengthranges from about 0.400 to about 0.800 inches.
 20. A method of providingtactile feedback for an aspirator comprising: providing an aspiratorsleeve comprising a sleeve wall, the sleeve wall defining a sleevecavity and a proximal sleeve end face; providing an aspirator handlecomprising a substantially cylindrical sleeve mount and a tubularmember, the tubular member extending from the substantially cylindricalsleeve mount; initiating interference between sleeve wall andsubstantially cylindrical sleeve mount when sleeve mount enters thesleeve cavity; and maintaining interference between sleeve wall andsubstantially cylindrical sleeve mount from initiation of interferenceuntil the aspirator sleeve is installed.
 21. The method of claim 20wherein maintaining interference further comprises varying level ofinterference while maintaining interference over a first portion of anengagement distance along the sleeve mount.
 22. The method of claim 21wherein varying level of interference further comprises increasing thelevel of interference in response to a first range of assembly forcesover the first portion of engagement distance along the sleeve mount.23. The method of claim 22 wherein varying level of interference furthercomprises increasing level of interference in response to a second rangeof assembly forces over a second portion of engagement distance alongthe sleeve mount.
 24. The method of claim 23 wherein a first rate ofincreasing assembly force for the first portion of the engagementdistance is greater than a second rate of increasing assembly force forthe second portion of the engagement distance.
 25. The method of claim24 wherein the first portion of the engagement distance includes aregion of the outer surface that initially interferes with substantiallycylindrical sleeve mount.
 26. The method of claim 24 wherein the secondportion of the engagement distance includes a region of the outersurface that is bounded proximally by a shoulder of the handle.
 27. Themethod of claim 20 further comprising moving substantially cylindricalsleeve mount into sleeve cavity over an engagement distance untilaspirator sleeve is installed on substantially cylindrical sleeve mount,wherein interference occurs over the engagement distance.
 28. The methodof claim 20 further comprising, in response to installation of sleeve onsleeve mount by a user, providing the tactile feedback to the userduring installation until the sleeve is fully engaged relative thesleeve mount.
 29. The method of claim 20 wherein the tactile feedback isan assembly force, wherein the assembly force provided to the user isincreasing until the sleeve reaches a shoulder disposed around thesleeve mount.
 30. The method of claim 20 wherein the interference ismaintained over an engagement length that ranges from about 0.400 toabout 0.800 inches.